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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

Subpart A--GENERAL PROVISIONS

�809.3

Definitions.

�809.4

Confidentiality of submitted information.

Subpart B--LABELING

�809.10

Labeling for in vitro diagnostic products.

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.