21 CFR 864.2800
§ 864.2800 Animal and human sera.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.2800, § 864.2800 Animal and human sera, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89314
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Full text
(a) Identification. Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.
(b) Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.