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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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Title 21
Chapter I
Part 809
Subpart C - Subpart C—Requirements for Manufacturers and Producers
§ 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.
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