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Part 809
FEDERAL · 21 CFR
Part 809 — In Vitro Diagnostic Products for Human Use
7 sections · Title 21: Food and Drugs
§ 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.