KIW · Kit, Mycoplasma Detection
Hematology · 21 CFR 864.2360 · Class 1
Overview
| Product Code | KIW |
|---|---|
| Device Name | Kit, 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K860695 | GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) | Gibco Laboratories Life Technologies, Inc. | Mar 12, 1986 | SESE |
| K851275 | GIBCO MYCOTECT 189-5670 | Gibco Laboratories Life Technologies, Inc. | Jun 21, 1985 | SESE |
Top Applicants
- Gibco Laboratories Life Technologies, Inc. — 2 clearances
