MYCOPLASMA HYORHINIS (BTS-7)
Device Facts
| Record ID | K781390 |
|---|---|
| Device Name | MYCOPLASMA HYORHINIS (BTS-7) |
| Applicant | Flow Laboratories, Inc. |
| Product Code | KPB · Hematology |
| Decision Date | Sep 1, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.2360 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.