21 C.F.R. PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

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Subpart A--GENERAL PROVISIONS

§809.3
Definitions.
§809.4
Confidentiality of submitted information.
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Subpart B--LABELING

§809.10
Labeling for in vitro diagnostic products.
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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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