Cepheid · Class II · Cleared Dec 3, 2015
| K-number | K151226 |
| Device name | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) |
| Applicant | Cepheid |
| Product code | OCC |
| Device class | Class II |
| Decision date | Dec 3, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 866.3980 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov