21 C.F.R. § 864.2360 Mycoplasma detection media and components.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart C—Cell And Tissue Culture Products
§ 864.2360 Mycoplasma detection media and components.
