[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13609-13632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04938]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1129]
Medical Devices; Exemptions From Premarket Notification: Class II
Devices; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) has
identified a list of class II devices that, when finalized, will be
exempt from premarket notification requirements, subject to certain
limitations. FDA is publishing this notice of that determination and
requesting public comment in accordance with procedures established by
the 21st
[[Page 13610]]
Century Cures Act. This notice does not represent FDA's final
determination with respect to the class II devices included in this
document. FDA will review any comments submitted within the 60-day
comment period and will consider whether the list of class II devices
should be modified prior to publication of its final determination in
the Federal Register.
DATES: Submit either electronic or written comments on the notice by
May 15, 2017. Late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before May 15, 2017. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of May 15, 2017.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-1129 for ``Medical Devices; Exemptions from Premarket
Notification: Class II Devices.'' Received comments, those filed in a
timely manner (see DATES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
and the amendments of the Safe Medical Devices Act of 1990 (Pub. L.
101-629), devices are to be classified into class I (general controls)
if there is information showing that the general controls of the FD&C
Act are sufficient to assure safety and effectiveness; into class II
(special controls), if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval), if there is insufficient information to support classifying
a device into class I or class II and the device is a life sustaining
or life supporting device or is for a use which is of substantial
importance in preventing impairment of human health or presents a
potential unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the FD&C Act through the
issuance of classification regulations into one of these three
regulatory classes. Devices introduced into interstate commerce for the
first time on or after May 28, 1976 (generally referred to as
postamendments devices) are classified through the premarket
notification process under section 510(k) of the FD&C Act (21 U.S.C.
360(k)). Section 510(k) of the FD&C Act and the implementing
regulations, part 807 of Title 21 of the Code of Federal Regulations
(CFR), require persons who intend to market a new device to submit a
premarket notification (510(k))
[[Page 13611]]
containing information that allows FDA to determine whether the new
device is ``substantially equivalent'' within the meaning of section
513(i) of the FD&C Act to a legally marketed device that does not
require premarket approval.
On December 13, 2016, the President signed into law the 21st
Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century
Cures Act amended section 510(m) of the FD&C Act. As amended, section
510(m)(1)(A) of the FD&C Act requires FDA to publish in the Federal
Register a notice containing a list of each type of class II device
that FDA determines no longer requires a report under section 510(k) of
the FD&C Act to provide reasonable assurance of safety and
effectiveness. FDA is required to publish this notice within 90 days of
the date of enactment of the 21st Century Cures Act and at least once
every 5 years thereafter, as FDA determines appropriate. Additionally,
FDA must provide at least a 60-day comment period for any such notice
required to be published under section 510(m)(1)(A) of the FD&C Act.
Within 210 days of enactment of the 21st Century Cures Act, FDA must
publish in the Federal Register a list representing its final
determination regarding the exemption of the devices that were
contained in the present list published under section 510(m)(1)(A) of
the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the
date of publication of the final list in the Federal Register, a 510(k)
will no longer be required for these devices and the classification
regulation applicable to each such type of device shall be deemed
amended to incorporate such exemption.
In a final action, and after considering comments, FDA intends to
amend the codified language for each listed regulation to reflect the
final determination with respect to exempt devices. FDA's final action
will decrease regulatory burdens on the medical device industry and
will eliminate private costs and expenditures required to comply with
Federal regulation. Specifically, regulated industry will no longer
have to invest time and resources in 510(k) notifications, including
preparation of documents and data for submission to FDA, payment of
user fees associated with 510(k) submissions, and responding to
questions and requests for additional information from FDA during
510(k) review.
II. Criteria for Exemption
There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the Agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff'' (Ref. 1).
III. Limitations on Exemptions
FDA believes that the types of class II devices listed in this
notice should be exempt from the premarket notification requirements
found under section 510(k) of the FD&C Act. However, an exemption from
the requirement of premarket notification does not mean that the device
is exempt from any other statutory or regulatory requirements, unless
such exemption is explicitly provided by order or regulation. FDA's
initial determination that premarket notification is unnecessary to
provide a reasonable assurance of safety and effectiveness for devices
listed in this document is based, in part, on the assurance of safety
and effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the
exemptions found in Sec. Sec. 862.9 to 892.9) 21 CFR 862.9 to 892.9,
FDA may partially limit the exemption from premarket notification
requirements to specific devices within a listed device type. In table
1, for example, FDA is listing the exemption of the endoscopic magnetic
retriever, but limits the exemption to such devices that are for single
use. All other endoscopic magnetic retrievers are still subject to
premarket notification requirements because FDA determined that
premarket notification is necessary to provide a reasonable assurance
of safety and effectiveness for these devices.
IV. List of Class II Devices
FDA is identifying the following list of class II devices that, if
finalized, would no longer require premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. Sec. 862.9 to 892.9:
Table 1--Class II Devices
------------------------------------------------------------------------
Partial exemption
21 CFR section Device type Product limitation (if
code applicable)
------------------------------------------------------------------------
862.1020............. Acid CJN ....................
Phosphatase,
Nitrophenylpho
sphate.
862.1020............. Acid CJR ....................
Phosphatase,
Thymol Blue
Monophosphate.
862.1020............. Acid CJX ....................
Phosphatase,
Disodium
Phenylphosphat
e.
862.1020............. Acid CKB ....................
Phosphatase,
Naphthyl
Phosphate.
862.1020............. Acid CKE ....................
Phosphatase,
Thymolphthale
Inmonophosphat
e.
862.1020............. Acid CKH ....................
Phosphatase,
Beta
Glycerophospha
te.
862.1020............. Acid JFH ....................
Phosphatase
(Prostatic),
Tartrate
Inhibited.
862.1090............. Radioassay, KQN ....................
Angiotensin
Converting
Enzyme.
862.1100............. Vanillin CIF ....................
Pyruvate, AST/
SGOT.
862.1100............. Diazo, AST/SGOT CIQ ....................
862.1100............. Hydrazone CIS ....................
Colorimetry,
AST/SGOT.
862.1100............. NADH Oxidation/ CIT ....................
NAD Reduction,
AST/SGOT.
862.1150............. Calibrator, JIS ....................
Primary.
862.1150............. Calibrator, JIT ....................
Secondary.
[[Page 13612]]
862.1150............. Calibrator, JIW ....................
Surrogate.
862.1150............. Calibrator, JIX ....................
Multi-Analyte
Mixture.
862.1345............. Drink, Glucose MRV ....................
Tolerance.
862.1350............. Continuous PJT ....................
Glucose
Monitor
Secondary
Display.
862.1445............. Chromatographic CEX ....................
Separation,
Lactate
Dehydrogenase
Isoenzymes.
862.1445............. Electrophoretic CFE ....................
, Lactate
Dehydrogenase
Isoenzymes.
862.1445............. Differential JGF ....................
Rate Kinetic
Method,
Lactate
Dehydrogenase
Isoenzymes.
862.1509............. System, Test, LPT ....................
Urinary
Methylmalonic
Acid.
862.1685............. Radioimmunoassa CEE ....................
y, Thyroxine-
Binding
Globulin.
862.1700............. Radioimmunoassa CDX ....................
y, Total
Thyroxine.
862.1700............. Enzyme KLI ....................
Immunoassay,
Non-
Radiolabeled,
Total
Thyroxine.
862.2265............. High Throughput PFF ....................
DNA Sequence
Analyzer.
862.2570............. Instrumentation NSU ....................
For Clinical
Multiplex Test
Systems.
862.2570............. Real Time OOI ....................
Nucleic Acid
Amplification
System.
862.2570............. Mass OTA ....................
Spectrometer
For Clinical
Multiplex Test
Systems.
862.2570............. Micro Total OUE ....................
Analysis
Instrument
System.
862.2570............. Complete Gene OVA ....................
Expression
Profiling
Accessory
Reagents.
862.2570............. DNA Genetic PCA ....................
Analyzer.
862.2570............. Data PQQ ....................
Acquisition
Software.
862.3100............. Enzyme DKZ Exemption is limited
Immunoassay, to test systems
Amphetamine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3100............. Radioimmunoassa DJP Exemption is limited
y, Amphetamine. to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3100............. Thin Layer DIT Exemption is limited
Chromatography to test systems
, Amphetamine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3100............. Gas DOD Exemption is limited
Chromatography to test systems
, Amphetamine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3100............. Liquid DNI Exemption is limited
Chromatography to test systems
, Amphetamine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3150............. Enzyme DJL Exemption is limited
Immunoassay, to test systems
Barbiturate. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3150............. Enzyme DIS Exemption is limited
Immunoassay, to test systems
Barbiturate. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
[[Page 13613]]
862.3150............. Radioimmunoassa DKN Exemption is limited
y, Barbiturate. to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3150............. Thin Layer DKX Exemption is limited
Chromatography to test systems
, Barbiturate. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3150............. Mercury DJN Exemption is limited
Dithiazone, to test systems
Colorimetry, intended for
Barbiturate. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3150............. Hemagglutinatio DLX Exemption is limited
n Inhibition, to test systems
Barbiturate. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3150............. Gas Liquid DMF Exemption is limited
Chromatography to test systems
, Barbiturate. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3150............. High Pressure KZY Exemption is limited
Liquid to test systems
Chromatography intended for
, Barbiturate. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3170............. Enzyme JXM Exemption is limited
Immunoassay, to test systems
Benzodiazepine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3170............. High Pressure LAA Exemption is limited
Liquid to test systems
Chromatography intended for
, employment and
Benzodiazepine. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3170............. Test, NFV Exemption is limited
Benzodiazepine to test systems
, Over The intended for
Counter. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3170............. Gas KZZ Exemption is limited
Chromatography to test systems
, intended for
Benzodiazepine. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3170............. Thin Layer LAB Exemption is limited
Chromatography to test systems
, intended for
Benzodiazepine. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3200............. Calibrators, DKB ....................
Drug Mixture.
862.3200............. Calibrators, DLJ ....................
Drug Specific.
862.3200............. Calibrators, DNN ....................
Ethyl Alcohol.
862.3250............. Enzyme DIO Exemption is limited
Immunoassay, to test systems
Cocaine and intended for
Cocaine employment and
Metabolites. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3250............. Radioimmunoassa KLN Exemption is limited
y, Cocaine to test systems
Metabolite. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
[[Page 13614]]
862.3250............. Enzyme JXO Exemption is limited
Immunoassay, to test systems
Cocaine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3250............. Hemagglutinatio DLN Exemption is limited
n, Cocaine to test systems
Metabolites intended for
(Benzoylecgoni employment and
ne). insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3250............. Thin Layer DMN Exemption is limited
Chromatography to test systems
, Cocaine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3250............. Free Radical DIR Exemption is limited
Assay, Cocaine. to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3250............. Gas DIN Exemption is limited
Chromatography to test systems
, Cocaine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3250............. Thin Layer DOM Exemption is limited
Chromatography to test systems
, intended for
Benzoylecgonin employment and
e. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3250............. High Pressure LAC Exemption is limited
Liquid to test systems
Chromatography intended for
, Cocaine and employment and
Cocaine insurance testing
Metabolites. and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3270............. High Pressure LAE Exemption is limited
Liquid to test systems
Chromatography intended for
, Codeine. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3270............. Thin Layer DLD Exemption is limited
Chromatography to test systems
, Codeine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3270............. Gas LAD Exemption is limited
Chromatography to test systems
, Codeine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3580............. Radioimmunoassa DLB Exemption is limited
y, LSD (125-I). to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3580............. Free Radical DOL Exemption is limited
Assay, LSD. to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3610............. Gas LAF Exemption is limited
Chromatography to test systems
, intended for
Methamphetamin employment and
e. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3610............. Thin Layer DJC Exemption is limited
Chromatography to test systems
, intended for
Methamphetamin employment and
e. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
[[Page 13615]]
862.3610............. High Pressure LAG Exemption is limited
Liquid to test systems
Chromatography intended for
, employment and
Methamphetamin insurance testing
e. and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3610............. Test, NGG Exemption is limited
Methamphetamin to test systems
e, Over The intended for
Counter. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3620............. Enzyme DJR Exemption is limited
Immunoassay, to test systems
Methadone. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3620............. Hemagglutinatio DIW Exemption is limited
n Inhibition, to test systems
Methadone. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3620............. Gas DMB Exemption is limited
Chromatography to test systems
, Methadone. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3620............. Thin Layer DKR Exemption is limited
Chromatography to test systems
, Methadone. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3620............. Liquid DNT Exemption is limited
Chromatography to test systems
, Methadone. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3620............. Free Radical DPP Exemption is limited
Assay, to test systems
Methadone. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3630............. Radioimmunoassa KXS Exemption is limited
y, to test systems
Methaqualone. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Thin Layer DNK Exemption is limited
Chromatography to test systems
, Morphine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Radioimmunoassa DOE Exemption is limited
y, Morphine to test systems
(123-I), Goat intended for
Antibody employment and
Ammonium insurance testing
Sulfate Sep.. and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Fluorometry, DJJ Exemption is limited
Morphine. to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Liquid DPK Exemption is limited
Chromatography to test systems
, Morphine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Gas DMY Exemption is limited
Chromatography to test systems
, Morphine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
[[Page 13616]]
862.3640............. Hemagglutinatio DLR Exemption is limited
n Inhibition, to test systems
Morphine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Free Radical DOK Exemption is limited
Assay, to test systems
Morphine. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Radioimmunoassa DIQ Exemption is limited
y, Morphine (3- to test systems
H), Goat intended for
Antibody employment and
Ammonium insurance testing
Sulfate Sep.. and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3640............. Radioimmunoassa DNA Exemption is limited
y, Morphine- to test systems
Barbiturate intended for
(125-I), Goat employment and
Antibody. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3650............. Enzyme DJG Exemption is limited
Immunoassay, to test systems
Opiates. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3650............. Gas DJF Exemption is limited
Chromatography to test systems
, Opiates. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3650............. Hemagglutinatio DLT Exemption is limited
n, Opiates. to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3650............. Thin Layer LAI Exemption is limited
Chromatography to test systems
, Opiates. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3650............. Free Radical DKT Exemption is limited
Assay, Opiates. to test systems
intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3650............. High Pressure LAH Exemption is limited
Liquid to test systems
Chromatography intended for
, Opiates. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3700............. Enzyme JXN Exemption is limited
Immunoassay, to test systems
Propoxyphene. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3700............. Thin Layer DPN Exemption is limited
Chromatography to test systems
, Propoxyphene. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3700............. Gas LAJ Exemption is limited
Chromatography to test systems
, Propoxyphene. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3700............. High Pressure LAK Exemption is limited
Liquid to test systems
Chromatography intended for
, Propoxyphene. employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
[[Page 13617]]
862.3870............. Enzyme LDJ Exemption is limited
Immunoassay, to test systems
Cannabinoids. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3870............. Reagents, Test, DKE Exemption is limited
Tetrahydrocann to test systems
abinol. intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3870............. Radioimmunoassa LAT Exemption is limited
y, to test systems
Cannabinoid(S). intended for
employment and
insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3910............. High Pressure LFI Exemption is limited
Liquid to test systems
Chromatography intended for
, Tricyclic employment and
Antidepressant insurance testing
Drugs. and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3910............. U.V. LFH Exemption is limited
Spectrometry, to test systems
Tricyclic intended for
Antidepressant employment and
Drugs. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
862.3910............. Thin Layer MLK Exemption is limited
Chromatography to test systems
, Tricyclic intended for
Antidepressant employment and
Drugs. insurance testing
and does not
include test
systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation
(DOT), and the U.S.
military.).
864.5400............. Fibrometer..... GIE ....................
864.5400............. Timer, JBT ....................
Coagulation.
864.5425............. Control, GGC ....................
Plasma,
Abnormal.
864.5425............. Plasma, GGN ....................
Coagulation
Control.
864.5425............. Plasma, GIZ ....................
Control,
Normal.
864.6550............. Control, Fecal OSL ....................
Occult Blood.
864.6650............. Study, Platelet JBZ ....................
Adhesive.
864.7275............. Test, JBO ....................
Euglobulin
Lysis.
864.7300............. Fibrin Monomer JBN ....................
Paracoagulatio
n.
864.7340............. Fibrinogen GFX ....................
Standard.
864.7340............. Plasma, GIL ....................
Fibrinogen
Control.
864.7375............. Glutathione, GII ....................
Red-Cell.
864.7375............. Fluorescence, JMH ....................
Visual
Observation
(Qual., U.V.),
Glutathione
Reductase.
864.7375............. Assay, KQF ....................
Glutathione
Reductase.
864.7415............. Control, JCM ....................
Hemoglobin,
Abnormal.
864.7455............. Stain, Fetal GHQ ....................
Hemoglobin.
864.7500............. Acid Hematin... GGF ....................
864.7720............. Test, GGQ ....................
Prothrombin
Consumption.
864.7735............. Prothrombin- JPF ....................
Proconvertin
and
Thrombotest.
864.8150............. Calibrator for KRX ....................
Cell Indices.
864.8165............. Calibrator for KRZ ....................
Hemoglobin and
Hematocrit
Measurement.
864.8175............. Calibrator for KRY ....................
Platelet
Counting.
864.8185............. Calibrator for KSA ....................
Red-Cell and
White-Cell
Counting.
864.8625............. Standards and GFS ....................
Controls,
Hemoglobin,
Normal and
Abnormal.
864.8625............. Control, White- GGL ....................
Cell.
864.8625............. Control, GGM ....................
Hemoglobin.
864.8625............. Control, GJP ....................
Platelet.
864.8625............. Control, Red- GJR ....................
Cell.
864.8625............. Control, GLK ....................
Hematocrit.
864.8625............. Mixture, GLQ ....................
Control, White-
Cell and Red-
Cell Indices.
864.8625............. Control, Cell JCN ....................
Counter,
Normal and
Abnormal.
864.8625............. Mixture, JPK ....................
Hematology
Quality
Control.
[[Page 13618]]
864.8625............. Material, NRF ....................
Quality
Control, Semen
Analysis.
864.8625............. Control NRS ....................
Material,
Blood
Circulating
Epithelial
Cancer Cell.
864.9400............. Solution, KSK ....................
Stabilized
Enzyme.
866.3395............. Norovirus OUC ....................
Serological
Reagents.
866.5210............. Immunochemical, CHN ....................
Ceruloplasmin.
866.5210............. Ceruloplasmin, DCT ....................
Rhodamine,
Antigen,
Antiserum,
Control.
866.5210............. Ceruloplasmin, DCY ....................
FITC, Antigen,
Antiserum,
Control.
866.5210............. Ceruloplasmin, DDB ....................
Antigen,
Antiserum,
Control.
866.5210............. P-Phenyl- JFQ ....................
Enediamine/
EDTA
(Spectrophotom
etric),
Ceruloplasmin.
866.5210............. Indirect Copper JFR ....................
Assay,
Ceruloplasmin.
866.5470............. Hemoglobin, DAM ....................
Chain
Specific,
Antigen,
Antiserum,
Control.
866.5620............. Alpha-2- DDT ....................
Macroglobulin,
Rhodamine,
Antigen,
Antiserum,
Control.
866.5620............. Alpha-2- DDY ....................
Macroglobulin,
FITC, Antigen,
Antiserum,
Control.
866.5620............. Alpha-2- DEB ....................
Macroglobulin,
Antigen,
Antiserum,
Control.
866.5630............. System, Test, JZG ....................
Beta-2-
Microglobulin
Immunological.
866.5750............. System, Test, DHB Exemption is limited
Radioallergoso to devices
rbent (RAST) classified under 21
Immunological. CFR 866.5750 that
are intended to
detect any of the
allergens included
in table 2 of this
document.
866.5910............. Quality Control NZB ....................
Material,
Genetics, DNA.
868.1040............. Algesimeter, BSI ....................
Powered.
868.1400............. Legging, LLK ....................
Compression,
Non-Inflatable.
868.2385............. Analyzer, MRQ Exemption is limited
Nitrogen to standalone
Dioxide. nitrogen dioxide
analyzers and not
those that are
components of
nitric oxide
delivery systems
intended to monitor
nitrogen dioxide
levels during
inhaled nitric
oxide therapy.
868.2500............. Monitor, KLK ....................
Oxygen,
Cutaneous, For
Infant Not
Under Gas
Anesthesia.
868.2500............. Monitor, LPP ....................
Oxygen,
Cutaneous, For
Uses Other
Than For
Infant Not
Under Gas
Anesthesia.
868.2550............. Pneumotachomete JAX ....................
r.
868.5180............. Bed, Rocking, CCO ....................
Breathing
Assist.
868.6250............. Compressor, BTI ....................
Air, Portable.
870.1330............. Wire, Guide, DQX Exemption is limited
Catheter. to accessory torque
devices that are
manually operated,
non-patient
contacting, and
intended to
manipulate non-
cerebral vascular
guide wires.
870.1390............. Trocar......... DRC ....................
870.1650............. Syringe, MAV Exemption is limited
Balloon to non-patient
Inflation. contacting balloon
inflation syringes
intended only to
inflate/deflate
balloon catheters
and monitor
pressure within the
balloon.
870.1875............. Lung Sound OCR ....................
Monitor.
870.2675............. Oscillometer... DRZ ....................
870.2770............. Analyzer, Body MNW Exemption is limited
Composition. to body composition
analyzers which are
not intended to
diagnose or treat
any medical
condition.
870.4280............. Filter, KRJ ....................
Prebypass,
Cardiopulmonar
y Bypass.
870.4290............. Adaptor, DTL ....................
Stopcock,
Manifold,
Fitting,
Cardiopulmonar
y Bypass.
870.4340............. Monitor and/or DTW ....................
Control, Level
Sensing,
Cardiopulmonar
y Bypass.
870.4400............. Reservoir, DTN Exemption is limited
Blood, to cardiopulmonary
Cardiopulmonar bypass blood
y Bypass. reservoirs that do
not contain
defoamers or blood
filters.
870.4420............. Sucker, DTS ....................
Cardiotomy
Return,
Cardiopulmonar
y Bypass.
870.4430............. Suction DWD ....................
Control,
Intracardiac,
Cardiopulmonar
y Bypass.
872.1720............. Tester, Pulp... EAT ....................
[[Page 13619]]
872.3260............. External PME ....................
Cleaning
Solution.
872.3300............. Coating, EBE ....................
Denture
Hydrophilic,
Resin.
872.3540............. Pad, Denture, EHR ....................
Over The
Counter.
872.3540............. Cushion, EHS ....................
Denture, Over
The Counter.
872.3560............. Reliner, EBP ....................
Denture, Over
The Counter.
872.3590............. Denture, ELM ....................
Plastic, Tooth.
872.3600............. Denture EKO ....................
Preformed
(Partially
Prefabricated
Denture).
872.3890............. Splint, ELS ....................
Endodontic
Stabilizing.
872.5550............. Ring, Teething, KKO ....................
Fluid-Filled.
872.6770............. Syringe, EJI ....................
Cartridge.
874.1090............. Tester, ETY Exemption is limited
Auditory to auditory
Impedance. impedance testers
that are in
compliance with FDA-
recognized
consensus standard
ANSI S3.39.
874.1090............. Tympanometer... NAS Exemption is limited
to tympanometers
that are in
compliance with FDA-
recognized
consensus standard
ANSI S3.39.
874.1120............. Generator, ETS ....................
Electronic
Noise (for
Audiometric
Testing).
874.1325............. Electroglottogr KLX ....................
aph.
874.3310............. Calibrator, ETW ....................
Hearing Aid/
Earphone and
Analysis
Systems.
874.3320............. Hearing Aid, EPF ....................
Group and
Auditory
Trainer.
874.3320............. Device, LZI ....................
Assistive
Listening.
874.3330............. Hearing Aid, KHL ....................
Master.
874.3430............. Mold, Middle- ETC ....................
Ear.
874.3730............. Device, Voice MCK ....................
Amplification.
876.1500............. Endoscopic FCC Exemption is limited
Magnetic to endoscopic
Retriever. magnetic retrievers
intended for single
use.
876.1500............. Light Source, FCQ ....................
Incandescent,
Diagnostic.
876.1500............. Light Source, FCR ....................
Photographic,
Fiberoptic.
876.1500............. Light Source, FCW ....................
Fiberoptic,
Routine.
876.1500............. Carrier, FGS ....................
Sponge,
Endoscopic.
876.1500............. Light Source, GCT ....................
Endoscope,
Xenon Arc.
876.1500............. Transformer, GCW ....................
Endoscope.
876.1500............. Scissors For KGD Exemption is limited
Cystoscope. to sterile scissors
for cystoscope
intended for single
use.
876.1500............. LED Light NTN ....................
Source.
876.1500............. Endoscopic OCY ....................
Guide Wire,
Gastroenterolo
gy-Urology.
876.1500............. Endoscopic OCZ Exemption is limited
Grasping/ to disposable, non-
Cutting powered endoscopic
Instrument, grasping/cutting
Non-Powered. instruments
intended for single
use.
876.4020............. Light, FCS ....................
Catheter,
Fiberoptic,
Glass,
Ureteral.
876.4270............. Rod, Colostomy. EZP ....................
876.4400............. Ligator, FHN ....................
Hemorrhoidal.
876.4400............. Ligator, MND ....................
Esophageal.
876.4500............. Lithotriptor, LQC ....................
Biliary
Mechanical.
876.4770............. Urethrotome.... EZO ....................
876.5010............. Bag, Bile EXF ....................
Collecting.
876.5010............. Catheter, GCA Exemption is limited
Biliary, to surgical biliary
Surgical. catheters that do
not include a
balloon component.
876.5025............. Vibrator for PIA ....................
Climax Control
of Premature
Ejaculation.
876.5365............. Dilator, EZM ....................
Esophageal
(Metal Olive)
Gastro-Urology.
876.5365............. Bougie, FAT ....................
Esophageal,
and
Gastrointestin
al, Gastro-
Urology.
876.5365............. Dilator, KNQ ....................
Esophageal.
876.5520............. Dilator, KOE ....................
Urethral.
876.5630............. Catheter, FJS Exemption is limited
Peritoneal, to non-patient
Long-Term contacting catheter
Indwelling. finger grips
intended for single
use.
876.5630............. Catheter, FKO Exemption is limited
Peritoneal to non-patient
Dialysis, contacting catheter
Single Use. finger grips
intended for single
use.
876.5630............. System, FKX Exemption is limited
Peritoneal, to continuous
Automatic ambulatory
Delivery. peritoneal dialysis
(CAPD) belts and
catheter stands
that do not include
weigh scales.
876.5665............. Disinfectant, NIH ....................
Subsystem,
Water
Purification.
876.5820............. Set, Dialyzer FKI ....................
Holder.
876.5895............. Irrigator, EXD ....................
Ostomy.
[[Page 13620]]
876.5980............. Catheter, FGD ....................
Retention,
Barium Enema
With Bag.
876.5980............. Gastrostomy PLI ....................
Tube Holder.
878.4370............. Drape, ERY ....................
Surgical, ENT.
878.4370............. Drape, Pure EYX ....................
Latex Sheet,
With Self-
Retaining
Finger Cot.
878.4370............. Drape, EYY ....................
Urological,
Disposable.
878.4370............. Pad, Kelly..... FNW ....................
878.4370............. Drape, Patient, HMT ....................
Ophthalmic.
878.4370............. Drape, HMW ....................
Microscope,
Ophthalmic.
878.4370............. Ring (Wound KGW ....................
Protector),
Drape
Retention,
Internal.
878.4370............. Drape, Surgical KKX Exemption is limited
to surgical drapes
that do not include
an antimicrobial
agent.
878.4495............. Suture, GAQ Exemption is limited
Nonabsorbable, to steel
Steel, monofilament
Monofilament sutures that are
And uncoated and do not
Multifilament, incorporate barbs.
Sterile.
878.4580............. Lamp, Operating- FQP ....................
Room.
878.4580............. Light, FSQ ....................
Surgical,
Instrument.
878.4580............. Light, FSS ....................
Surgical,
Floor Standing.
878.4580............. Light, FSW ....................
Surgical,
Endoscopic.
878.4580............. Light, FSX ....................
Surgical,
Connector.
878.4580............. Light, FSY ....................
Surgical,
Ceiling
Mounted.
878.4580............. Light, FSZ ....................
Surgical,
Carrier.
878.4580............. Light, FTA ....................
Surgical,
Accessories.
878.4580............. Lamp, Surgical. FTD ....................
878.4580............. Illuminator, FTG ....................
Remote.
878.4580............. Lamp, Surgical, GBC ....................
Incandescent.
878.5070............. Apparatus, Air FZG ....................
Handling,
Bench.
878.5070............. Apparatus, Air FZH ....................
Handling, Room.
878.5070............. Apparatus, Air FZI ....................
Handling,
Enclosure.
880.5580............. Locator, BWJ ....................
Acupuncture
Point.
880.5580............. Needle, MQX ....................
Acupuncture,
Single Use.
880.5780............. Stocking, DWL ....................
Medical
Support (to
Prevent
Pooling of
Blood in Legs).
882.1020............. Analyzer, GZM ....................
Rigidity.
882.1470............. Computerized PKQ Exemption is limited
Cognitive to computerized
Assessment Aid. cognitive
assessment aids
that are not
intended for
diagnostic
assessment of
specific diseases
or conditions and
rely on inputs from
visual cues,
auditory cues, and/
or functional use
of the hand.
882.1540............. Device, GZO ....................
Galvanic Skin
Response
Measurement.
882.1560............. Device, Skin HCJ ....................
Potential
Measurement.
882.1855............. Encephalogram GYE ....................
Telemetry
System.
882.5895............. Vibratory OVP ....................
Counter-
Stimulation.
884.1630............. Colposcope (and HEX Exemption is limited
Colpomicroscop to standard
e). colposcopes (and
colpomicroscopes)
that use only a
white light source,
do not use filters
other than a green
filter, do not
include image
analysis software,
and are not
smartphone-based.
884.2990............. Sheet, NHM ....................
Recording,
Breast
Examination.
884.3200............. Drain, Cervical HFL ....................
884.4400............. Forceps, HDA ....................
Obstetrical.
884.4530............. Tenaculum, HDC Exemption is limited
Uterine. to sterile urterine
tenaculum devices
that do not use
suction and are
intended for single
use.
884.4530............. Clamp, HFW ....................
Umbilical.
884.4530............. Speculum, HIB ....................
Vaginal,
Nonmetal.
884.4530............. Speculum, HIC ....................
Vaginal,
Nonmetal,
Fiberoptic.
884.4530............. Clamp and NBZ ....................
Cutter,
Umbilical.
884.4900............. Table, HDD ....................
Obstetrical,
AC-Powered
(and
Accessories).
884.4900............. Table, HHP ....................
Obstetrical,
Manual (and
Accessories).
884.4900............. Table, KNC ....................
Obstetric (and
Accessories).
884.5200............. Hemorrhoid OOA ....................
Prevention
Pressure Wedge.
884.5390............. Heater, HGZ ....................
Perineal,
Direct Contact.
884.5390............. Heater, HHA ....................
Perineal,
Radiant, Non-
Contact.
884.5390............. Heater, KND ....................
Perineal.
884.5400............. Cup, Menstrual. HHE ....................
[[Page 13621]]
884.5425............. Pad, Menstrual, HHL ....................
Scented.
884.6120............. Accessory, MQG Exemption is limited
Assisted to single embryo
Reproduction. incubators with
temperature, gas,
and humidity
control only;
syringe pumps;
collection tube
warmers; dish/plate/
microscope stage
warmers; and
controlled-rate
cryopreservation
freezers.
884.6130............. Microtools, MQH Exemption is limited
Assisted to assisted
Reproduction reproduction
(Pipettes). microtools
(pipettes)
manufactured from
glass.
884.6150............. Micromanipulato MQJ ....................
rs and
Microinjectors
, Assisted
Reproduction.
884.6160............. Labware, MQK Exemption is limited
Assisted to dishes and
Reproduction. plates that are
intended for
general assisted
reproduction
technology
procedures.
886.1120............. Photorefractor. MMF ....................
886.1120............. Camera, PJZ ....................
Ophthalmic,
General-Use.
886.1250............. Euthyscope, AC- HMK ....................
Powered.
886.1570............. Ophthalmoscope, HLI ....................
AC-Powered.
886.1570............. Ophthalmoscope, HLJ ....................
Battery-
Powered.
886.1570............. Ophthalmoscopes MSG ....................
, Replacement
Batteries,
Hand-Held.
886.1780............. Retinoscope, AC- HKL ....................
Powered.
886.1850............. Biomicroscope, HJO Exemption is limited
Slit-Lamp, AC- to slit-lamp, AC-
Powered. powered
biomicroscopes
intended only for
the visual
examination of the
anterior segment of
the eye, are
classified as Group
1 per FDA-
recognized
consensus standard
ANSI Z80.36, do not
provide any
quantitative
output, and are not
intended for
screening or
automated
diagnostic
indications.
886.1945............. Transilluminato HJM ....................
r, AC-Powered.
886.3320............. Ocular Peg..... MQU Exemption is limited
to ocular pegs
supplied sterile.
886.4150............. Tubing, MSR ....................
Replacement,
Phacofragmenta
tion Unit.
886.4250............. Unit, HRO ....................
Electrolysis,
AC-Powered,
Ophthalmic.
886.4335............. Headlight, FCT ....................
Fiberoptic
Focusing.
886.4335............. Light, FSR ....................
Headband,
Surgical.
886.4335............. Headlamp, HPQ ....................
Operating, AC-
Powered.
886.4400............. Locator, Metal, HPM ....................
Electronic.
886.4440............. Magnet, AC- HPO ....................
Powered.
886.4790............. Sponge, HOZ ....................
Ophthalmic.
886.4790............. Eye Tray....... OJK ....................
888.1240............. Dynamometer, AC- LBB ....................
Powered.
888.4580............. Instrument, JDX ....................
Surgical,
Sonic and
Accessory/
Attachment.
888.4580............. System, Cement LZV ....................
Removal
Extraction.
890.1450............. Hammer, Reflex, IKO ....................
Powered.
890.5100............. Bath, Hydro- ILJ ....................
Massage.
890.5100............. Bath, Sitz, ILM ....................
Powered.
890.5110............. Bath, Paraffin. IMC ....................
890.5250............. Cabinet, Moist IMB ....................
Steam.
890.5360............. Exerciser, ISD ....................
Measuring.
890.5500............. Lamp, Infrared, ILY ....................
Therapeutic
Heating.
890.5575............. Device, IRN ....................
Warning,
Overload,
External Limb,
Powered.
892.1000............. MRI Disposable OIM ....................
Kit.
892.1560............. Biopsy Needle OIJ ....................
Guide Kit.
892.1610............. Aperature, IZS ....................
Radiographic.
892.1610............. Cone, IZT ....................
Radiographic.
892.1610............. Collimator, IZW ....................
Automatic,
Radiographic.
892.1610............. Collimator, IZX ....................
Manual,
Radiographic.
892.1610............. Device, Beam KPW ....................
Limiting, X-
Ray,
Diagnostic.
892.1650............. Arthrogram Tray OII ....................
892.1650............. Radiology OIK ....................
Dental Tray.
892.1670............. Device, Spot- IXL ....................
Film.
892.1680............. Radiographic OIO ....................
Contrast Tray.
892.1680............. Radiology OIP ....................
Diagnostic Kit.
892.1730............. Discography Kit OIL ....................
892.1820............. Chair, HBK ....................
Pneumocephalog
raphic.
892.1850............. Cassette, IXA ....................
Radiographic
Film.
892.1860............. Changer, KPX ....................
Radiographic
Film/Cassette.
892.1870............. Programmer, IZP ....................
Changer, Film/
Cassette,
Radiographic.
[[Page 13622]]
892.1900............. Controller, EGT ....................
Temperature,
Radiographic.
892.1900............. Dryer, Film, EGW ....................
Radiographic.
892.1900............. Processor, EGY ....................
Radiographic-
Film,
Automatic,
Dental.
892.1900............. Processor, IXW ....................
Radiographic-
Film,
Automatic.
892.1900............. Processor, Cine IXX ....................
Film.
892.2030............. Digitizer, LMA ....................
Image,
Radiological.
892.2030............. Digitizer, NFH ....................
Images,
Ophthalmic.
892.2040............. Camera, Multi LMC ....................
Format,
Radiological.
892.2040............. Device, NFI ....................
Hardcopy,
Images,
Ophthalmic.
892.5730............. Prostate OIN ....................
Seeding Kit.
------------------------------------------------------------------------
In table 1, FDA included devices classified under Sec. 866.5750
(Radioallergosorbent (RAST) immunological test system, product code
``DHB''). FDA does not believe that all devices with the product code
DHB meet the exemption criteria from premarket notification
requirements. However, FDA is identifying a substantial amount of these
devices for exemption in table 2.
Table 2--Class II Devices (Sec. 866.5750--Radioallergosorbent (RAST)
Immunological Test Systems)
------------------------------------------------------------------------
Source (taxonomical
Allergen code Allergen product name)
------------------------------------------------------------------------
Grass Pollens
------------------------------------------------------------------------
g1......................... Sweet vernal grass... Anthoxanthum
odoratum.
g3......................... Cocksfoot grass, Dactylis glomerata.
Orchard grass.
g4......................... Meadow fescue........ Festuca elatior.
g5......................... Rye-grass (perennial Lolium perenne.
rye grass).
g7......................... Common reed (common Phragmites communis.
reed grass).
g8......................... Meadow grass, Poa pratensis.
Kentucky blue (June
grass).
g9......................... Redtop, Bentgrass.... Agrostis
stolonifera,
Agrostis gigantea
(Agrostis alba).
g11........................ Brome grass.......... Bromus inermis.
g12........................ Cultivated rye Secale cereale.
(cultivated rye
grass).
g13........................ Velvet grass......... Holcus lanatus.
g14........................ Cultivated oat Avena sativa.
(cultivated oat
grass).
g15........................ Cultivated wheat Triticum aestivum
(cultivated wheat (Triticum spp.).
grass).
g16........................ Meadow foxtail Alopecurus
(meadow foxtail pratensis.
grass).
g17........................ Bahia grass.......... Paspalum notatum.
g24........................ Wheat grass, Western. Agropyron smithii
(Elymus smithii).
g30........................ Bluegrass, annual.... Poa annua.
g70........................ Wild rye grass....... Elymus triticoides,
Elymus condensatus.
g71........................ Canary grass......... Phalaris
arundinacea.
g201....................... Barley, cultivated... Hordeum vulgare.
g202....................... Maize, corn Zea mays.
(cultivated corn).
g203....................... Salt grass........... Distichlis spicata.
g204....................... False oat-grass...... Arrhenatherum
elatius.
g216....................... Cyn d 1.............. Cynodon dactylon.
g701....................... Phl p 1.0102, Phl p Phleum pratense.
5.0101.
g702....................... Phl p 7.0101......... Phleum pratense.
g703....................... Phl p 12.0101........ Phleum pratense.
------------------------------------------------------------------------
Weed Pollens
------------------------------------------------------------------------
w2......................... Western ragweed...... Ambrosia
psilostachya.
w4......................... False ragweed........ Ambrosia
acanthicarpa
(Franseria
acanthicarpa).
w5......................... Wormwood............. Artemisia
absinthium,
Artemisia annua.
w6......................... Mugwort.............. Artemisia vulgaris.
w7......................... Marguerite, ox-eye Chrysanthemum
daisy. leucanthemum.
w8......................... Dandelion............ Taraxacum vulgare,
Taraxacum
officinale.
w9......................... Plantain (English), Plantago lanceolata.
Ribwort.
w10........................ Goosefoot, lamb's Chenopodium album.
quarters.
w11........................ Saltwort (prickly), Salsola kali
Russian thistle. (Salsola pestifer).
w12........................ Goldenrod............ Solidago virgaurea
(Solidago spp.).
w13........................ Cocklebur, common.... Xanthium commune.
w14........................ Common pigweed (rough Amaranthus
pigweed). retroflexus.
w15........................ Scale, Lenscale...... Atriplex
lentiformis.
[[Page 13623]]
w16........................ Rough marsh elder.... Iva ciliate, Iva
annua.
w17........................ Firebush (Kochia).... Kochia scoparia.
w18........................ Sheep sorrel......... Rumex acetosella.
w19........................ Wall pellitory....... Parietaria
officinalis.
w20........................ Nettle (Common Urtica dioica.
stinging nettle).
w21........................ Wall pellitory....... Parietaria judaica.
w22........................ Japanese hop Humulus japonicas
(careless weed). (Humulus scandens).
w23........................ Yellow dock, Yellow Rumex crispus.
dockweed.
w24........................ Spiny pigweed........ Amaranthus spinosus.
w27........................ Carnation............ Dianthus spp.
w28........................ Rose................. Rosa rugosa.
w33........................ Clover............... Trifolium pratense.
w35........................ Mexican tea.......... Chenopodium
ambrosioides.
w36........................ Rabbit bush.......... Ambrosia deltoidea
(Franseria
deltoides).
w37........................ Salt bush, annual.... Atriplex wrightii.
w39........................ Water hemp, Western.. Amaranthus rudis
(Acnida
tamariscina).
w41........................ Burrobrush........... Hymenoclea salsola.
w42........................ Poverty weed.........
w43........................ Common sagebrush..... Artemisia
tridentata.
w45........................ Alfalfa.............. Medicago sativa.
w46........................ Dog fennel........... Eupatorium
capillifolium.
w53........................ Geranium............. Geranium spp.
w67........................ Groundsel bush....... Baccharis
halimifolia.
w69........................ Iodine bush.......... Allenrolfea
occidentalis.
w70........................ Ragweed, slender..... Ambrosia
confertiflora.
w75........................ Wing scale Atriplex canescens.
(wingscale).
w82........................ Careless weed........ Amaranthus palmeri,
Amaranthus
hybridus.
w90........................ Japanese hop......... Humulus japonicas
(Humulus scandens).
w203....................... Rape (rape pollen)... Brassica napus.
w204....................... Sunflower............ Helianthus annuus.
w206....................... Camomile............. Matricaria
chamomilla.
w207....................... Lupin................ Lupinus spp.
w210....................... Sugar-beet........... Beta vulgaris.
w211....................... Par j 2.0101......... Parietaria judaica.
w231....................... Art v 1.............. Artemisia vulgaris
(Mugwort).
w232....................... Sal k 1.............. Salsola kali.
w233....................... Art v 3.............. Artemisa vulgaris
(LTP, Mugwort).
w234....................... Pla l 1.............. Plantago lanceolata.
w235....................... Che a 1.0101......... Chenopodium album.
w236....................... Mer a 1.0101......... Mercurialis annua.
a753....................... Art v 1.............. Artemisia vulgaris
(Mugwort weed).
------------------------------------------------------------------------
Tree Pollens
------------------------------------------------------------------------
t1......................... Box-elder (Maple).... Acer negundo, Acer
saccharum.
t2......................... Gray alder, speckled Alnus incana.
alder (alder).
t4......................... Hazel, hazelnut...... Corylus avellana,
Corylus americana.
t5......................... American beech Fagus grandifolia
(beech). (Fagus americana).
t6......................... Mountain juniper, Juniperus ashei
Mountain cedar. (Juniperus
sabinoides).
t8......................... Elm.................. Ulmus americana.
t9......................... Olive................ Olea europaea.
t10........................ Walnut............... Juglans californica,
Juglans nigra.
t11........................ Maple leaf sycamore, Platanus acerifolia.
London plane, Plane
tree.
t61........................ Sycamore............. Platanus
occidentalis.
t12........................ Willow............... Salix caprea, Salix
nigra.
t14........................ Cottonwood (Eastern Populus deltoides.
Cottonwood/Black
Cottonwood).
t15........................ White ash............ Fraxinus americana.
t16........................ White pine........... Pinus strobus.
t18........................ Eucalyptus, gum-tree. Eucalyptus globulus
(Eucalyptus spp.).
t19/t26.................... Acacia............... Acacia longifolia
(Acacia spp.).
t20........................ Mesquite............. Prosopis glandulosa/
Prosopis juliflora.
t21........................ Melaleuca, cajeput Melaleuca
tree. quinquenervia
(Melaleuca
leucadendron).
t22........................ Pecan, hickory....... Carya illinoinensis
(Carya pecan).
t23........................ Italian/Mediterranean/ Cupressus
funeral cypress. sempervirens.
t24........................ Japanese cypress..... Chamaecyparis obtusa
(Chamaecyparis
spp.).
t25........................ Ash.................. Fraxinus excelsior.
t27........................ Maple, red........... Acer rubrum.
t29........................ Acacia............... Acacia spp.
t30........................ Birch, white......... Betula populifolia.
[[Page 13624]]
t32........................ Willow, black........ Salix nigra.
t33........................ Ash, Arizona......... Fraxinus velutina.
t35........................ Cedar, salt.......... Tamarix gallica.
t37........................ Bald cypress (white Taxodium distichum.
bald cypress).
t38........................ Elm, Chinese/Siberian Ulmus pumila.
t40........................ Hazelnut tree........ Corylus americana.
t41........................ White hickory........ Carya alba (Carya
tomentosa).
t42........................ Oak, red............. Quercus rubra.
t43........................ Loblolly pine........ Pinus taeda.
t44........................ Hackberry............ Celtis occidentalis.
t45........................ Cedar elm............ Ulmus crassifolia.
t47........................ Juniper, one seed.... Juniperus
monosperma.
t48........................ Pine, lodgepole...... Pinus contorta.
t49........................ Pine, ponderosa...... Pinus ponderosa.
t50........................ Beech, European...... Fagus sylvatica.
t51........................ Tree of Heaven....... Ailanthus altissima.
t52........................ Western white pine... Pinus monticola.
t54........................ Russian olive........ Elaeagnus
angustifolia.
t55........................ Scotch broom......... Cytisus scoparius.
t56........................ Bayberry............. Myrica cerifera.
t57........................ Red cedar............ Juniperus
virginiana.
t60........................ Western juniper...... Juniperus
occidentalis.
t61........................ Sycamore............. Platanus
occidentalis.
t70........................ Mulberry (white Morus alba.
mulberry).
t71........................ Red mulberry......... Morus rubra.
t72........................ Queen palm........... Arecastrum
romanzoffiamon.
t73........................ Australian pine...... Casuarina
equisetifolia.
t77........................ Oak mix (red, white, Quercus spp.
black).
t80........................ Japanese cypress..... Chamaecyparis
obtusa.
t81........................ Japanese alder....... Alnus japonica.
t83........................ Mango tree........... Mangifera indica.
t90........................ Walnut, black........ Juglans nigra.
t96........................ Poplar, white Populus alba.
(poplar).
t103/t218.................. Virginia live oak Quercus virginiana.
(live oak).
t105....................... Pepper tree.......... Schinus molle.
t110....................... Orange tree.......... Citrus sinensis.
t201....................... Spruce, Norway spruce Picea abies (Picea
excelsa).
t202....................... Alder, smooth........ Alnus incana spp.
Rugosa (Alnus
rugosa).
t203....................... Horse chestnut....... Aesculus
hippocastanum.
t205....................... Elder................ Sambucus nigra.
t206....................... Chestnut............. Castanea sativa.
t207....................... Douglas fir.......... Pseudotsuga
menziesii
(Pseudotsuga
taxifolia).
t208....................... Linden............... Tilia cordata.
t209....................... Horn beam............ Carpinus betulus.
t210....................... Privet............... Ligustrum vulgare.
t211....................... Sweet gum............ Liquidambar
styraciflua.
t212....................... Cedar................ Libocedrus
decurrens.
t213....................... Pine................. Pinus radiata.
t214....................... Date palm............ Phoenix canariensis.
t215....................... Lilac................ Syringa vulgaris.
t217....................... Pepper tree.......... Schinus molle.
t217....................... Red alder............ Alnus rubra.
t218....................... Virginia live oak.... Quercus virginiana.
t218....................... Bayberry (bayberry/ Myrica gale.
sweet gale).
t219....................... Palo verde........... Cercidium floridum.
t219....................... Red cedar............ Juniperus
virginiana.
t220....................... Bet v 4.............. Betula verrucosa
(Birch).
t221....................... Bet v 2.0101, Bet v 4 Betula verrucosa
(Birch).
t222....................... Cypress (Arizona Cupressus arizonica.
cypress).
t223....................... Oil palm............. Elaeis guineensis.
t224....................... Ole e 1.............. Olea europaea.
t225....................... Bet v 6.............. Betula verrucosa
(Birch).
t226....................... Cup a 1.............. Cupressus arizonica.
t227....................... Ole e 7.............. Olea Europaea.
t228....................... Aspen, quaking....... Populus tremuloides.
t229....................... Eastern hemlock...... Tsuga canadensis.
t230....................... Redwood (sequoia).... Sequoia
sempervirens.
t232....................... Pussy willow......... Salix discolor.
t240....................... Ole e 9.0101......... Olea Europaea.
t241....................... Pla a 1.0101......... Platanus acerifolia.
[[Page 13625]]
t242....................... Pla a 2.............. Platanus acerifolia.
t243....................... Pla a 3.0101......... Platanus acerifolia.
t244....................... Cor a 1.0103......... Corylus avellana.
t245....................... Aln g 1.0101......... Alnus glutinosa.
t246....................... Cry j 1.............. Cryptomeria
japonica.
t280....................... Locust tree.......... Robinia
pseudoacacia.
t401....................... Brazilian peppertree. Schinus
terebinthifolius.
t402....................... Mastic tree.......... Pistacia lentiscus.
t404....................... Tree of heaven....... Ailanthus altissima.
t406....................... Date palm............ Phoenix dactylifera.
a482....................... Ole e 1.............. Olea europaea (Olive
Oil).
------------------------------------------------------------------------
Mites
------------------------------------------------------------------------
d207....................... Blo t 5.0101......... Blomia tropicalis.
d208....................... Lep d 2.0101......... Lepidoglyphus
destructor.
------------------------------------------------------------------------
Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1......................... Penicillium Penicillium
chrysogenum chrysogenum
(Penicillium (Penicillium
notatum). notatum).
m2......................... Cladosporium herbarum Cladosporium
(Hormodendrum). herbarum
(Hormodendrum).
m3......................... Aspergillus fumigatus Aspergillus
fumigatus.
m4......................... Mucor racemosus...... Mucor racemosus.
m5......................... Candida albicans..... Candida albicans.
m7......................... Botrytis cinerea..... Botrytis cinerea.
m8......................... Drechslera halodes Drechslera halodes
(Setomelanomma (Setomelanomma
rostrata, rostrata,
Helminthosporium Helminthosporium
halodes, halodes).
Helminthosporium
interseminatum).
m9......................... Fusarium moniliforme Fusarium moniliforme
(Fusarium (Fusarium
proliferatum). proliferatum).
m10........................ Stemphylium botryosum Stemphylium herbarum
(Stemphylium
botryosum).
m11........................ Rhizopus nigricans... Rhizopus nigricans.
m12........................ Aureobasidium Aureobasidium
pullulans. pullulans.
m13........................ Phoma betae.......... Phoma betae.
m14........................ Epicoccum Epicoccum
purpurascens. purpurascens
(Epicoccum nigrum).
m15........................ Trichoderma viride... Trichoderma viride.
m16........................ Curvularia lunata.... Curvularia lunata
Curvularia
specifera
(K923044).
m17........................ Cladosporium fulvum.. Cladosporium fulvum.
m18........................ Fusarium culmorum.... Fusarium culmorum.
m19........................ Aspergillus Aspergillus
versicolor. versicolor.
m20........................ Mucor mucedo......... Mucor mucedo.
m21........................ Aspergillus clavatus. Aspergillus
clavatus.
m22........................ Micropolyspora faeni. Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m23........................ Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m24........................ Stachybotrys atra.... Stachybotrys
chartarum
(Stachybotrys
atra).
m24........................ Paecilomyces spp..... Paecilomyces spp.
m25........................ Aspergillus Aspergillus
versicolor. versicolor.
m25........................ Penicillium Penicillium
brevicompactum. brevicompactum.
m26........................ Cladosporium Cladosporium
cladosporioides. cladosporioides.
m26........................ Penicillium citrinum. Penicillium
citrinum.
m27........................ Penicillium spp...... Penicillium spp.
m29........................ Aspergillus repens... Aspergillus repens.
m30........................ Penicillium Penicillium
roqueforti. roqueforti.
m32........................ Cladosporium Cladosporium
cladosporioides. cladosporioides.
m34........................ Serpula lacrymans.... Serpula lacrymans.
m36........................ Aspergillus terreus.. Aspergillus terreus.
m37........................ Trichophyton Trichophyton
mentagrophytes. mentagrophytes.
m40........................ Aspergillus Aspergillus
amstelodami. amstelodami.
m43........................ Saccharomyces Saccharomyces
carlsberg. carlsbergensis.
m44........................ Saccharomyces Saccharomyces
cerevisiae. cerevisiae.
m45........................ Hormodendrum hordei.. Hormodendrum hordei.
m46........................ Bipolaris spicifera.. Bipolaris spicifera.
m47........................ Aspergillus nidulans. Aspergillus
nidulans.
m48........................ Aspergillus oryzae... Aspergillus oryzae.
m49........................ Fusarium oxysporum... Fusarium oxysporum.
m50........................ Micropolyspora faeni. Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m51........................ Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m53........................ Microspora canis..... Microsporum canis
(Microspora canis).
m54........................ Aspergillus flavus... Aspergillus flavus.
m63........................ Helminthosporium Helminthosporium
intersemin. intersemin.
m66........................ Mucor plumbeus....... Mucor plumbeus.
[[Page 13626]]
m67........................ Mycogone............. Mycogone perniciosa.
m68........................ Nigrospora oryzae.... Nigrospora oryzae.
m69........................ Rhodotorula.......... Rhodotorula rubra
(Rhodotorula
mucilaginosa).
m70........................ Malassezia furfur Malassezia furfur
(Pityrosporum (Pityrosporum
orbiculare). orbiculare).
m71........................ Spondylocladium...... Spondylocladium spp.
m72........................ Epidermophyton....... Epidermophyton
floccosum.
m73........................ Epicoccum nigrum..... Epicoccum
purpurascens
(Epicoccum nigrum).
m80........................ Staphylococcal Staphylococcus
enterotoxin A (Sta a aureus.
SEA).
m80........................ Helminthosporium spp. Helminthosporium
spp.
m81........................ Staphylococcal Staphylococcus
enterotoxin B (Sta a aureus.
SEB).
m88........................ Stemphylium solani... Stemphylium solani.
m93........................ Gliocladium Gliocladium
fimbriatum. fimbriatum.
m94........................ Phycomyces Phycomyces
blakesleeanus. blakesleeanus.
m201....................... Tilletia tritici Tilletia tritici
(Ustilago nuda, (Ustilago nuda,
Ustilago tritici) Ustilago tritici).
(Barley smut).
m202....................... Acremonium kiliense Acremonium kiliense
(Cephalosporium (Cephalosporium
acremonium). acremonium).
m203....................... Trichosporon Trichosporon
pullulans. pullulans.
m204....................... Ulocladium chartarum. Ulocladium
chartarum.
m205....................... Trichophyton rubrum.. Trichophyton rubrum.
m207....................... Aspergillus niger.... Aspergillus niger.
m208....................... Chaetomium globosum.. Chaetomium globosum.
m209....................... Penicillium Penicillium glabrum
frequentans. (Penicillium
frequentans).
m209....................... Stachybotrys Stachybotrys
chartarum. chartarum
(Stachybotrys
atra).
m210....................... Trichophyton Trichophyton
mentagrophytes var. mentagrophytes var.
goetzii. goetzii.
m211....................... Trichophyton Trichophyton
mentagrophytes var. mentagrophytes var.
interdigitale. interdigitale.
m211....................... Oat smut............. Ustilago avenae.
m212....................... Micropolyspora faeni. Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m212....................... Geotrichum candidum.. Geotrichum candidum.
m213....................... Bermuda grass smut... Ustilago cynodontis.
m214....................... Johnson grass smut... Sphacelotheca
cruenta.
m215....................... Corn smut............ Ustilago maydis.
m218....................... Asp f 1.0101......... Aspergillus
fumigatus.
a3050...................... Asp r 1.............. Aspergillus
restrictus.
m219....................... Asp f 2.............. Aspergillus
fumigatus.
m220....................... Asp f 3.0101......... Aspergillus
fumigatus.
m221....................... Asp f 4.............. Aspergillus
fumigatus.
m222....................... Asp f 6.0101......... Aspergillus
fumigatus.
m223....................... Staphylococal Staphylococus
enterotoxin C (Sta a aureus.
SEC).
m224....................... Staphylococcal Staphylococcus
enterotoxin D (Sta a aureus.
SED).
m226....................... Staphylococcal Staphylococcus
enterotoxin TSST aureus.
(Sta a TSST).
m227....................... Malassezia spp. Malassezia spp.
(Pityrosporum spp.). (Pityrosporum
spp.).
m228....................... Aspergillus flavus. ....................
m229....................... Alt a 1.0101......... Alternaria alternata
(Alternaria
tenuis).
m230....................... Alt a 6.0101......... Alternaria alternata
(Alternaria
tenuis).
m231....................... Cla h 8.0101......... Cladosporium
herbarum
(Hormodendrum).
m300....................... Eurotium spp......... Eurotium spp.
m304....................... Aspergillus oryzae... Aspergillus oryzae.
m305....................... Penicillium Penicillium
brevicompactum. brevicompactum.
m309....................... Aspergillus terreus.. Aspergillus terreus.
m310....................... Aspergillus nidulans. Aspergillus
nidulans.
m311....................... Aspergillus flavus... Aspergillus flavus.
m312....................... Aspergillus clavatus. Aspergillus
clavatus.
------------------------------------------------------------------------
Epidermal & Animal
------------------------------------------------------------------------
e6......................... Guinea pig epithelium Cavia porcellus.
e7......................... Pigeon droppings..... Columba palumbus,
Columba livia.
e25........................ Chicken serum........ Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e26........................ Parrot serum......... Psittacoidea spp.
e62........................ Camel................ Camelus dromedaries.
e70........................ Goose feathers....... Anser anser.
e71........................ Mouse epithelium..... Mus musculus (Mus
spp.).
e73........................ Rat epithelium....... Rattus norvegicus.
e74........................ Rat urine proteins... Rattus norvegicus
Rattus rattus.
e75........................ Rat serum proteins... Rattus norvegicus
Rattus rattus.
e76........................ Mouse serum proteins. Mus musculus (Mus
spp.).
e77........................ Budgerigar droppings. Melopsittacus
undulatus.
e78........................ Budgerigar feathers.. Melopsittacus
undulatus.
e79........................ Budgerigar serum Melopsittacus
proteins. undulatus.
e80........................ Goat epithelium...... Capra hircus.
[[Page 13627]]
e81........................ Sheep epithelium..... Ovis aries (Ovis
spp.).
e82........................ Rabbit epithelium.... Oryctolagus
cuniculus
(Oryctolagus spp.).
e83........................ Swine epithelium..... Sus scrofa (Sus
scrofa domesticus;
Sus spp.).
e84........................ Hamster epithelium... Cricetus cricetus,
Mesocricetus
auratus, and
Phodopus sungorus.
e85........................ Chicken feathers..... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e86........................ Duck feathers........ Anas platyrhynchos.
e87........................ Rat epithelium, serum Rattus norvegicus
proteins, and urine Rattus rattus.
proteins.
e88........................ Mouse epithelium, Mus musculus (Mus
serum proteins, and spp.).
urine proteins
(mouse).
e89........................ Turkey feathers...... Meleagris gallopavo.
e90........................ Budgerigar serum Melopsittacus
proteins, feathers, undulatus.
and droppings.
e91........................ Pigeon serum Streptopelia
proteins, feathers, roseogrisea
and droppings. Psittacidae spp.
e92........................ Parrot serum Ara spp.
proteins, feathers,
and droppings.
e93........................ Pigeon serum proteins Streptopelia
roseogrisea.
e94........................ Fel d 1.0101......... Felis domesticus.
a345....................... Fel d 1.............. Felis domesticus.
e98........................ Parrot droppings..... Psittacoidea spp.
e101....................... Can f 1.0101......... Canis familiaris
(Canis domesticus).
a174....................... Can f 1.............. Canis familiaris
(Canis domesticus).
e102....................... Can f 2.0101......... Canis familiaris
(Canis domesticus).
e196....................... Parakeet feathers.... Nymphicus
hollandicus.
e197....................... Parakeet droppings... Nymphicus
hollandicus.
e198....................... Parakeet serum....... Nymphicus
hollandicus.
e199....................... Canary bird serum.... Serinus canarius.
e200....................... Canary bird droppings Serinus canarius.
e201....................... Canary bird feathers Serinus canarius.
(Canary feathers).
e202....................... Reindeer epithelium.. Rangifer tarandus.
e203....................... Mink epithelium...... Mustela spp.
e204....................... Bos d 6.............. Bos domesticus (Bos
taurus; Bos spp.).
e205....................... Horse, serum proteins Equus caballus
(Equus spp.).
e206....................... Rabbit, serum Oryctolagus
proteins. cuniculus
(Oryctolagus spp.).
e208....................... Chinchilla epithelium Chinchilla laniger.
e209....................... Gerbil epithelium.... Meriones
unguiculatus.
e210....................... Fox epithelium....... Vulpes vulpes.
e211....................... Rabbit, urine Oryctolagus
proteins. cuniculus
(Oryctolagus spp.).
e212....................... Swine, urine proteins Sus scrofa (Sus
scrofa domesticus;
Sus spp.).
e213....................... Parrot feathers...... Ara spp.
e214....................... Finch feathers....... Lonchura domestica.
e215....................... Pigeon feathers...... Streptopelia
roseogrisea
(Streptopelia
spp.), Columbia
spp.
e216....................... Deer epithelium...... Dama dama.
e217....................... Ferret epithelium.... Mustela putorius.
e218....................... Chicken droppings.... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e219....................... Chicken, serum Gallus domesticus
proteins. (Gallus gallus
domesticus; Gallus
spp.).
e220....................... Fel d 2, Cat serum Felis domesticus.
albumin.
e221....................... Can f 3.............. Canis familiaris
(Canis domesticus)
(Dog serum
albumin).
e222....................... Swine serum albumin Sus scrofa (Sus
(Sus s PSA). scrofa domesticus;
Sus spp.).
e225....................... Lovebird feathers.... Psittacoidea
agapomis.
e226....................... Can f 5.0101......... Canis familiaris.
e227....................... Equ c 1.0101......... Equus caballus.
e228....................... Fel d 4.0101......... Felis domesticus.
e230....................... Equ c 3.............. Equus caballus.
e231....................... Mus m 1.............. Mus musculus.
------------------------------------------------------------------------
Food
------------------------------------------------------------------------
f9......................... Rice................. Oryza sativa.
f12........................ Pea (green pea)...... Pisum sativum.
f15........................ White bean........... Phaseolus vulgaris.
f19........................ Cayenne pepper....... Capsicum frutescens,
(Capsicum annum).
f21........................ Sugar cane........... Saccharum
officinarum.
f22........................ Raspberry............ Rubus idaeus.
f26........................ Pork................. Sus scrofa (Sus
scrofa domesticus;
Sus spp.).
f29........................ Watermelon........... Citrullus lanatus
(Citrullus
vulgaris).
f31........................ Carrot............... Daucus carota.
f32........................ Oyster mushroom...... Pleurotus ostreatus.
[[Page 13628]]
f33........................ Orange............... Citrus sinensis.
f35........................ Potato............... Solanum tuberosum.
f43........................ Mother's milk........ Homo sapiens.
f44........................ Strawberry........... Fragaria vesca
(Fragaria spp.).
f45........................ Yeast, baker's....... Saccharomyces
cerevisiae.
f46........................ Pepper, Red.......... Capsicum annuum.
f47........................ Garlic............... Allium sativum.
f48........................ Onion................ Allium cepa.
f49........................ Apple................ Malus x domestica
(Malus spp.).
f51........................ Bamboo shoot......... Phyllostachys
pubescens.
f52........................ Cacao/chocolate...... Theobroma cacao.
f54........................ Sweet potato......... Ipomoea batatas.
f55........................ Common millet........ Panicum miliaceum.
f56........................ Foxtail millet....... Setaria italica.
f57........................ Japanese millet...... Echinochloa crus-
galli.
f58........................ Pacific squid........ Todarodes pacificus.
f59........................ Octopus.............. Octopus vulgaris
(Octopus spp.).
f63........................ Kefir................ NA.
f67........................ Parmesan cheese...... NA.
f81........................ Cheese, cheddar type. NA.
f82........................ Cheese, mold type.... NA.
f83........................ Chicken.............. Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
f86........................ Parsley.............. Petroselinum
crispum.
f87........................ Melon................ Cucumis melo Cucumis
melo + Citrullus
lanatus.
f88........................ Mutton (lamb)........ Ovis aries (Ovis
spp.).
f90........................ Malt................. Hordeum vulgare.
f92........................ Banana............... Musa spp.
f93........................ Cacao................ Theobroma cacao.
f94........................ Pear................. Pyrus communis
(Pyrus spp.).
f97........................ Yam.................. Dioscorea spp.,
Dioscorea opposita.
f97........................ Chamomile tea........ Matricaria
chamomilla.
f98........................ Gliadin.............. Triticum aestivum
(Triticum spp.).
f102....................... Cantaloupe........... Cucumis melo var.
cantalupensis.
f105....................... Chocolate............ Theobroma cacao.
f109....................... Cottonseed........... Gossypium hirsutum.
f110....................... Giant radish......... Raphanus sativus.
f118....................... Zucchini............. Cucurbita pepo.
f119....................... Radish............... Raphanus sativus.
f120....................... Venison.............. Capreolus capeolus.
f121....................... Pinto bean........... Phaseolus vulgaris.
f122....................... Cheese, American..... NA.
f127....................... Black-eyed pea....... Vigna unguiculata.
f131....................... Black Olive.......... Olea europaea.
f136....................... Red beet............. Beta vulgaris var.
conditiva.
f139....................... Goat's Cheese........ Capra aegagrus.
f140....................... Bran................. NA.
f141....................... Corn (vegetables).... Zea mays.
f152....................... Green bell pepper.... Capsicum annuum.
f155....................... Brewer's yeast....... Saccharomyces
carlsbergensis.
f157....................... Duck................. Anas domesticus.
f158....................... Goose................ Anser anser.
f160....................... Camembert cheese..... NA.
f162....................... Nectarine............ Prunus persica var.
nucipersica.
f163....................... Kohlrabi............. Brassica oleracea
var. gongylodes.
f65........................ Perch ....................
f166....................... Leek................. Allium porrum.
f170....................... Cheese (Switzerland) NA.
(Swiss cheese).
f174....................... Fig.................. Ficus carica.
f177....................... Cranberry............ Vaccinium
macrocarpon.
f179....................... Raisin............... Vitis spp.
f182....................... Lima bean............ Phaseolus lunatus.
f198....................... Flaxseed (bruised Linum usitatissimum.
grain).
f199....................... Untreated native milk Bos domesticus (Bos
taurus; Bos spp.).
f208....................... Lemon................ Citrus limon.
f209....................... Grapefruit........... Citrus paradisi.
f210....................... Pineapple............ Ananas comosus.
f211....................... Blackberry........... Rubus fruticosus.
f212....................... Mushroom (champignon) Agaricus hortensis
(Agaricus spp.).
f213....................... Rabbit............... Oryctolagus
cuniculus
(Oryctolagus spp.).
[[Page 13629]]
f214....................... Spinach.............. Spinacia oleracea.
f215....................... Lettuce.............. Lactuca sativa.
f216....................... Cabbage.............. Brassica oleracea
var. capitata.
f217....................... Brussels sprouts..... Brassica oleracea
var. gem.
f218....................... Paprika, sweet pepper Capsicum annuum.
f219....................... Fennel seed.......... Foeniculum vulgare.
f219....................... Sage................. Salvia officinalis.
f220....................... Cinnamon............. Cinnamomum spp.
f221....................... Coffee............... Coffea spp.
f222....................... Tea.................. Camellia sinensis.
f223....................... Green olive.......... Olea europaea.
f225....................... Summer squash, Cucurbita pepo.
pumpkin.
f225....................... Pumpkin.............. Cucurbita maxima.
f226....................... Pumpkin seed......... Cucurbita pepo.
f227....................... Sugar-beet seed...... Beta vulgaris.
f229....................... Safflower Seed....... Carthamus
tinctorius.
f231....................... Milk, boiled......... Bos domesticus (Bos
taurus; Bos spp.).
f234....................... Vanilla.............. Vanilla planifolia.
f237....................... Apricot.............. Prunus armeniaca.
f241....................... Gouda cheese......... NA.
f242....................... Cherry............... Prunus avium.
f244....................... Cucumber............. Cucumis sativus.
f246....................... Guar, guar gum....... Cyamopsis
tetragonoloba.
f247....................... Honey................ NA.
f248....................... Rosemary............. Rosmarinus
officinalis.
f254....................... Plaice............... Pleuronectes
platessa.
f255....................... Plum................. Prunus domestica,
Prunus americana.
f258....................... Squid................ Loligo spp.
f259....................... Grape................ Vitis vinifera
(Vitis spp.).
f260....................... Broccoli............. Brassica oleracea
var. italica
(Brassica oleracea
var. cultivar).
f261....................... Asparagus............ Asparagus
officinalis.
f262....................... Aubergine, eggplant.. Solanum melongena.
f263....................... Green pepper......... Piper nigrum,
Capsicum annuum.
f264....................... Eel.................. Anguilla anguilla.
f265....................... Caraway.............. Carum carvi.
f265....................... Cumin................ Cuminum cyminum.
f266....................... Mace................. Myristica fragrans.
f267....................... Cardamon............. Elettaria
cardamomum.
f268....................... Clove................ Syzygium aromaticum.
f269....................... Basil................ Ocimum basilicum.
f270....................... Ginger............... Zingiber officinale.
f271....................... Anise................ Pimpinella anisum.
f272....................... Tarragon............. Artemisia
dracunculus.
f273....................... Thyme................ Thymus vulgaris.
f274....................... Marjoram............. Origanum majorana.
f275....................... Lovage............... Levisticum
officinale.
f276....................... Fennel, fresh........ Foeniculum vulgare.
f277....................... Dill................. Anethum graveolens.
f278....................... Bay leaf............. Laurus nobilis.
f279....................... Chili pepper......... Capsicum frutescens.
f280....................... Black pepper......... Piper nigrum.
f281....................... Curry (Santa Maria).. NA.
f282....................... Nutmeg............... Myristica fragrans.
f283....................... Oregano.............. Origanum vulgare.
f284....................... Turkey meat.......... Meleagris gallopavo.
f285....................... Elk/moose meat....... Alces spp.
f286....................... Mare's milk.......... Equus caballus
(Equus spp.).
f287....................... Red kidney bean...... Phaseolus vulgaris.
f288....................... Blueberry............ Vaccinium myrtillus
(Vaccinium spp.).
f289....................... Date................. Phoenix dactylifera.
f291....................... Cauliflower.......... Brassica oleracea
var. botrytis.
f292....................... Guava................ Psidium guajava.
f293....................... Papaya............... Carica papaya.
f294....................... Passion fruit, Passiflora edulis
Maracuja. (Passiflora spp.).
f295....................... Carambola............ Averrhoa carambola.
f296....................... Carob................ Ceratonia siliqua.
f297....................... Gum arabic........... Acacia senegal
(Acacia spp.).
f298....................... Tragacanth........... Astragalus spp.
f299....................... Sweet chestnut Castanea sativa.
(chestnut).
[[Page 13630]]
f300....................... Pinto bean........... Phaseolus spp.
f301....................... Persimmon (kaki Diospyros kaki.
fruit, sharon).
f302....................... Mandarin (tangerine, Citrus reticulata.
clementine,
satsumas).
f305....................... Fenugreek............ Trigonella foenum-
graecum.
f306....................... Lime................. Citrus aurantifolia.
f307....................... Hake................. Merluccius
merluccius.
f308....................... Sardine (pilchard)... Sardina pilchardus.
f310....................... Blue vetch........... Lathyrus sativus.
f311....................... Megrim............... Lepidorhombus
whiffiagonis.
f315....................... Green bean........... Phaseolus vulgaris.
f316....................... Rape seed............ Brassica napus.
f317....................... Coriander............ Coriandrum sativum.
f318....................... Jack fruit........... Artocarpus
heterophyllus.
f319....................... Beetroot............. Beta vulgaris.
f320....................... Crayfish............. Astacus astacus.
f321....................... Horse meat........... Equus caballus
(Equus spp.).
f322....................... Red currant.......... Ribes sylvestre.
f324....................... Hop (fruit cone)..... Humulus lupulus.
f325....................... Saffron.............. Colchicum autumnale.
f328....................... Fig.................. Ficus carica.
f329....................... Watermelon........... Citrullus lanatus.
f330....................... Rose hip............. Rosa spp.
f331....................... Saffron.............. Crocus sativus.
f332....................... Mint................. Mentha piperita.
f333....................... Linseed.............. Linum usitatissimum.
f336....................... Jujube............... Ziziphus jujuba.
f336....................... Wine vinegar......... Vitis vinifera
(Vitis spp.).
f337....................... Sole................. Solea solea.
f337....................... English sole......... Parophrys vetulus.
f338....................... Wine, white.......... Vitis vinifera
(Vitis spp.).
f339....................... Allspice............. Pimenta dioica.
f339....................... Wine, red............ Vitis vinifera
(Vitis spp.).
f341....................... Cranberry............ Vaccinium oxycoccus,
Vaccinium
macrocarpon.
f342....................... Olive (black, fresh). Olea europaea.
f343....................... Raspberry............ Rubus idaeus.
f344....................... Sage................. Salvia officinalis.
f346....................... Chives............... Allium
schoenoprasum.
f347....................... Quinoa............... Chenopodium quinoa.
f348....................... Litchi............... Litchi chinensis.
f349....................... Chum salmon roe...... Oncorhynchus keta.
f358....................... Artichoke............ Cynara scolymus.
f360....................... Yogurt............... NA.
f368....................... Black bass........... Micropterus dolomieu
(Micropterus
dolomieui).
f374....................... Karaya gum........... Sterculia urens.
f375....................... Horseradish.......... Armoracia rusticana.
f377....................... Maple syrup.......... NA.
f379....................... Okra................. Abelmoschus
esculentus.
f382....................... Beet, sugar.......... Beta vulgaris var.
altissima.
f401....................... Loquat............... Eriobotrya japonica.
f402....................... Fig.................. Ficus carica.
f403....................... Brewer's yeast....... Saccharomyces
cerevisiae.
f405....................... Mint................. Mentha spp.
f406....................... Arugula.............. Eruca vesicaria.
------------------------------------------------------------------------
House Dust
------------------------------------------------------------------------
h1......................... Greer Labs., Inc..... NA.
h2......................... Hollister-Stier Labs. NA.
h6......................... Japan................ NA.
------------------------------------------------------------------------
Venoms & Insects
------------------------------------------------------------------------
i7......................... Midge................ Chironomus
yoshimatsui.
i8......................... Moth................. Bombyx mori,
Heterocera spp.
i47........................ Water flea........... Daphnia spp.
i49........................ Deer fly............. Chrysops spp.
i51........................ Black ant............ Camponotus
pennsylvanicus.
i54........................ Flea mix (dog/cat), Ctenocephalides spp.
common flea.
i71........................ Mosquito............. Aedes communis,
Aedes spp. and
Culex spp.
i72........................ Green nimitti........ Cladotanytarsus
lewisi.
[[Page 13631]]
i73........................ Blood worm........... Chironomus thummi,
Chironomusri
parius, Chironomus
spp.
i75........................ European hornet...... Vespa crabro.
i76........................ Berlin beetle........ Trogoderma angustum.
i77........................ European paper wasp.. Polistes dominulus.
i78........................ Fly.................. Musca domestica.
i80........................ Bumblebee............ Bombus
pennsylvanicus.
i201....................... Horse bot fly........ Gasterophilus
intestinalis.
i202....................... Grain weevil......... Sitophilus
granarius.
i203....................... Mediterranean flour Ephestia kuehniella
moth. (Anagasta
kuehniella).
i204....................... Horse fly............ Tabanus spp.
i205....................... Bumblebee............ Bombus terrestris.
i208....................... Api m 1.0101......... Apis mellifera.
a45........................ Api m 1.............. Apis mellifera.
i209....................... Ves v 5.0101......... Vespula vulgaris.
a670....................... Ves v 5.............. Vespula vulgaris.
i210....................... Pol d 5.0101......... Polistes dominulus.
i211....................... Ves v 1.0101......... Vespula vulgaris.
i213....................... Api m 4.............. Apis mellifera.
i214....................... Api m 2.............. Apis mellifera.
i215....................... Api m 3.............. Apis mellifera.
i216....................... Api m 5.............. Apis mellifera.
i217....................... Api m 10............. Apis mellifera.
i220....................... Bla g 1.0101......... Blattella germanica.
i221....................... Bla g 2.0101......... Blattella germanica.
i222....................... Bla g 5.0101......... Blattella germanica.
i223....................... Bla g 7.............. Blattella germanica.
a46........................ Api m 2.............. Apis mellifera.
------------------------------------------------------------------------
Miscellaneous
------------------------------------------------------------------------
o1......................... Cotton, crude fibers. Gossypium spp.
o3......................... Cotton (treated)..... Gossypium spp.
o70........................ Seminal fluid........ Homo sapiens.
o71........................ Staphylococcus aureus Staphylococcus
aureus.
o72........................ Pichia pastoris crude Pichia pastoris.
extract customer
specific.
o72........................ Sperm-sediment....... Homo sapiens.
o73........................ Pichia pastoris crude Pichia pastoris.
extr. vector
customer specific.
o74........................ Pichia pastoris with Pichia pastoris.
vector customer
specific.
o201....................... Tobacco leaf, tobacco Nicotiana tabacum.
dust.
o202....................... Artemia salina, fish Artemia salina.
feed.
o203....................... Tetramin, fish feed.. NA.
o207....................... Daphnia, fish feed... Daphnia spp.
o211....................... Mealworm............. Tenebrio molitor.
o212....................... Streptavidin......... Streptomyces
avidini.
o213....................... MBP (maltose binding Escherichia coli.
protein).
o214....................... CCD; MUXF3 from Ananas comosus.
bromelain.
o72........................ Enterotoxin A (Sta a Staphylococcus
SEA). aureus.
o73........................ Enterotoxin B (Sta a Staphylococcus
SEB). aureus.
------------------------------------------------------------------------
Parasites
------------------------------------------------------------------------
p1......................... Ascaris.............. Ascaris suum.
p2......................... Echinococcus......... Echinococcus
granulosus.
p3......................... Schistosoma.......... Schistosoma mansoni.
p4......................... Anisakis (Herring Anisakis simplex
Worm). (Anisakis spp.).
p5......................... Toxocara canis....... Toxocara canis.
p10........................ Ani s 3.0101......... Anisakis simplex
(Anisakis spp.).
p11........................ Ani s 1.............. Anisakis simplex
(Anisakis spp.).
------------------------------------------------------------------------
Occupational
------------------------------------------------------------------------
k4......................... Threshing dust....... NA.
k5......................... Flax................. NA.
k7......................... Hay Dust............. NA.
k8......................... Hop (hops)........... Humulus lupulus.
k12........................ Grain mill dust...... NA.
k14........................ Kapok................ NA.
k20........................ Sheep's wool Ovis aries (Ovis
(treated) (wool). spp.).
k21........................ Sheep's wool Ovis aries (Ovis
(Untreated). spp.).
[[Page 13632]]
k23........................ Straw Dust........... NA.
k33........................ Oak.................. NA.
k70........................ Green coffee bean.... Coffea spp.
k71........................ Castor bean.......... Ricinus communis.
k72........................ Ispaghula............ Plantago psyllium/
Plantago ovata.
k73........................ Silk waste........... NA.
k74........................ Silk................. Bombyx mori.
k75........................ Isocyanate TDI NA.
(Toluene
diisocyanate).
k76........................ Isocyanate MDI NA.
(Diphenylmethane
diisocyanate).
k77........................ Isocyanate HDI NA.
(Hexamethylen
diisocyanate).
k78........................ Ethylene oxide....... NA.
k79........................ Phthalic anhydride... NA.
k80........................ Formaldehyde/Formalin NA.
k81........................ Ficus................ Ficus benjamina
(Ficus spp.).
k83........................ Cotton seed.......... Gossypium hirsutum.
k84........................ Sunflower seed....... Helianthus annuus.
k85........................ Chloramin T.......... NA.
k86........................ Trimellitic NA.
anhydride, TMA.
k87........................ Asp o 21, alpha- Aspergillus oryzae.
amylase.
k89........................ Orris root........... Iris florentina.
k99........................ HSA (Human Serum Homo sapiens.
Albumin) (Hom s HSA).
k201....................... Car p 1, Papain...... Carica papaya.
k202....................... Ana c 2, Bromelain... Ananas comosus.
k204....................... Maxatase............. Bacillus
licheniformis.
k205....................... Alcalase............. Bacillus spp.
k206....................... Savinase, Protease 1 Bacillus spp.
(Bac l Subtilisin).
k208....................... Gal d 4, Lysozyme.... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
k209....................... Hexahydrophtalic NA.
anhydrid.
k210....................... Maleic anhydride..... NA.
k211....................... Methyltetrahydrophtal NA.
ic anhydrid.
k212....................... Abachi wood dust..... Triplochiton
scleroxylon.
k213....................... Pepsin (Sus s Pepsin) Sus scrofa (Sus
scrofa domesticus;
Sus spp.).
k213....................... TCPA................. NA.
k214....................... Bougainvillea........ Bougainvillea spp.
k225....................... Horse radish Armoracia rusticana.
peroxidase (Arm r
HRP).
k226....................... Ascorbate oxidase Cucurbita pepo.
(Cuc p ascorbate
oxidase).
k301....................... Flour dust........... Triticum spp.
k501....................... Savinase customer Proprietary
specific. knowledge of
customer.
k502....................... Lipolase customer Proprietary
specific. knowledge of
customer.
k503....................... Termamyl customer Proprietary
specific. knowledge of
customer.
k504....................... Clazinase customer Proprietary
specific. knowledge of
customer.
------------------------------------------------------------------------
V. Reference
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. FDA Guidance, ``Procedures for Class II Device Exemptions from
Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04938 Filed 3-13-17; 8:45 am]
BILLING CODE 4164-01-P