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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN...
PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
§ 809.3 - Definitions.
§ 809.4 - Confidentiality of submitted information.
§ 809.10 - Labeling for in vitro diagnostic products.
§ 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
§ 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.