21 C.F.R. · Food and Drugs
21 C.F.R. § 864.2280

Cultured animal and human cells.

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21 C.F.R. § 864.2280 — Cultured animal and human cells.

§ 864.2280 Cultured animal and human cells. (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. [45 FR 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

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21 C.F.R. § 864.2280
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The regulatory text of 21 C.F.R. § 864.2280 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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