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Title 21 - Title 21

Part 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

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MEDICAL DEVICES - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

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7 sections

§809.10 - Labeling for in vitro diagnostic products.

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§809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.

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§809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

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§809.3 - Definitions.

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§809.30 - Restrictions on the sale, distribution and use of analyte specific reagents.

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§809.4 - Confidentiality of submitted information.

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§809.40 - Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

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