GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
Device Facts
| Record ID | K860695 |
|---|---|
| Device Name | GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) |
| Applicant | Gibco Laboratories Life Technologies, Inc. |
| Product Code | KIW · Hematology |
| Decision Date | Mar 12, 1986 |
| 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.