StacksVerified U.S. regulatory reference

21 CFR §864.2800

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.