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
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Confidentiality of submitted information.
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Subpart B--LABELING
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Labeling for in vitro diagnostic products.
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Subpart C--REQUIREMENTS FOR MANUFACTURERS AND PRODUCERS
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General requirements for manufacturers and producers of in vitro diagnostic products.
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Restrictions on the sale, distribution and use of analyte specific reagents.
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Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
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