§ 864.2280. Cultured animal and human cells.
77 words·~1 min read·
/us/cfr/t21/s§ 864.2280·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]