Cepheid®
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories6
Latest Approval2025-05-01
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250995 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-05-01 | View |
| 510(k) | K250996 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-05-01 | View |
| 510(k) | K243730 | Xpert C. difficile/Epi | OZN | 2025-02-28 | View |
| 510(k) | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | QQX | 2025-01-15 | View |
| 510(k) | K243625 | Xpert MRSA/SA SSTI | NQX | 2024-12-18 | View |
| 510(k) | K243405 | Xpert vanA | NIJ | 2024-11-21 | View |
| 510(k) | K243070 | Xpert® SA Nasal Complete | NQX | 2024-10-25 | View |
| 510(k) | K230440 | Xpert® Xpress CoV-2 plus | QQX | 2023-10-13 | View |
| 510(k) | K231481 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2023-08-17 | View |
| 510(k) | K223046 | Xpert® FII & FV | NPR | 2023-02-15 | View |
No matching devices.