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Code of Federal Regulations
Title 21
Chapter I
Subchapter H
Part 809
Subpart C
Requirements for Manufacturers and Producers
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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.