MYCOPLASMA DETECTION KIT
Device Facts
| Record ID | K771867 |
|---|---|
| Device Name | MYCOPLASMA DETECTION KIT |
| Applicant | Bioassay Systems Research Corp. |
| Product Code | KPB · Hematology |
| Decision Date | Nov 17, 1977 |
| 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.
