21 CFR 864.2360 — Kit, Mycoplasma Detection
Hematology (HE) · Part 864 Subpart C—Cell And Tissue Culture Products · § 864.2360
Identification
Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIW | Kit, Mycoplasma Detection | 1 | 2 | |
| KIX | Media, Mycoplasma Detection | 1 | 0 | |
| KPB | Media And Components, Mycoplasma Detection | 1 | 4 |
