WI-38 GENCELLS
Device Facts
| Record ID | K851561 |
|---|---|
| Device Name | WI-38 GENCELLS |
| Applicant | Genus Diagnostics |
| Product Code | KIR · Hematology |
| Decision Date | May 10, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.2280 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
