Cepheid
FDA 510(k) & PMA Approved Dispositivos — 38 products
Publicidade
Total de dispositivos38
Categorias0
Última decisão da FDA
| Tipo | Número | Nome do dispositivo | Código | Data | Ações |
|---|---|---|---|---|---|
| 510(k) | K261336 | Xpert Respiratory Panel | QOF | 2026-09-25 | Ver |
| 510(k) | K261362 | Xpert Hemorrhagic Fever | QVR | 2026-08-07 | Ver |
| 510(k) | K261867 | Xpert Carba-R | POC | 2026-07-02 | Ver |
| 510(k) | K253653 | Xpert Hemorrhagic Fever | 2026-02-20 | Ver | |
| 510(k) | K251721 | Xpert GI Panel | PCH | 2026-01-16 | Ver |
| 510(k) | K250996 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-05-01 | Ver |
| 510(k) | K250995 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-05-01 | Ver |
| 510(k) | K243730 | Xpert C. difficile/Epi | OZN | 2025-02-28 | Ver |
| 510(k) | K250218 | Xpert® FII & FV | NPR | 2025-02-21 | Ver |
| 510(k) | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | QQX | 2025-01-15 | Ver |
| 510(k) | K242071 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-01-10 | Ver |
| 510(k) | K243625 | Xpert MRSA/SA SSTI | NQX | 2024-12-18 | Ver |
| 510(k) | K243405 | Xpert vanA | NIJ | 2024-11-21 | Ver |
| 510(k) | K243070 | Xpert® SA Nasal Complete | NQX | 2024-10-25 | Ver |
| 510(k) | K231381 | Xpert Xpress MVP; GeneXpert Xpress System | PQA | 2023-10-19 | Ver |
| 510(k) | K230440 | Xpert® Xpress CoV-2 plus | QQX | 2023-10-13 | Ver |
| 510(k) | K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | NJR | 2023-09-27 | Ver |
| 510(k) | K231481 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2023-08-17 | Ver |
| 510(k) | K223046 | Xpert® FII & FV | NPR | 2023-02-15 | Ver |
| 510(k) | K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | PQA | 2022-06-07 | Ver |
Nenhum dispositivo correspondente.