21 CFR § 864.2220 Hematology and Pathology Devices

§ 864.2220 Synthetic cell and tissue culture media and components.

Current through Sep 8, 2026 · Read all of Part 864

(a) Identification. Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the survival and development of cell lines of humans and other animals. This does not include tissue culture media for human ex vivo tissue and cell culture processing applications as described in § 876.5885 of this chapter.

(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 the limitations in § 864.9.

[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 27024, May 16, 2001; 66 FR 38789, July 25, 2001]

← § 864.1890 In situ hybridization test systems for use with a corresponding approved oncology therapeutic product.§ 864.2240 Cell and tissue culture supplies and equipment. →