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 PDF809.5 Exemption from batch certification requirements for in vitro antibiotic susceptibility devices subject to section 507 of the act.
TEXT PDF809.6 Conditions on the effectiveness of exemptions of antibiotic susceptibility devices from batch certification requirements.
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.

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