Title 21--Food and Drugs

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

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

TEXT PDF809.3 Definitions.
TEXT PDF809.4 Confidentiality of submitted information.
TEXT PDF809.10 Labeling for in vitro diagnostic products.
TEXT PDF809.10 Labeling for in vitro diagnostic products.
TEXT PDF809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
TEXT PDF809.30 Restrictions on the sale, distribution and use of analyte specific reagents.
TEXT PDF809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

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