21 CFR 864.2280
§ 864.2280 Cultured animal and human cells.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.2280, § 864.2280 Cultured animal and human cells, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89312
- Permanent ID
ys:prov:89312@1- SHA-256
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Full text
(a) Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 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.