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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter HPart 809


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

rule

Subpart A—GENERAL PROVISIONS

§809.3
Definitions.
§809.4
Confidentiality of submitted information.
rule

Subpart B—LABELING

§809.10
Labeling for in vitro diagnostic products.
§809.11
Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
rule

Subpart C—REQUIREMENTS FOR MANUFACTURERS AND PRODUCERS

§809.20
General requirements for manufacturers and producers of in vitro diagnostic products.
§809.30
Restrictions on the sale, distribution and use of analyte specific reagents.
§809.40
Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

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