21 CFR 864.2360
§ 864.2360 Mycoplasma detection media and components.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.2360, § 864.2360 Mycoplasma detection media and components, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89313
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.