864.2800 Animal and human sera.§ 864.2800 Animal and human sera.
(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.[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]