KIX · Media, Mycoplasma Detection
Hematology · 21 CFR 864.2360 · Class 1
Overview
| Product Code | KIX |
|---|---|
| Device Name | Media, Mycoplasma Detection |
| Regulation | 21 CFR 864.2360 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
