§ 864.2360. Mycoplasma detection media and components.
76 words·~1 min read·
/us/cfr/t21/s§ 864.2360·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.
(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]