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Cepheid®

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories7
Latest FDA decision2026-07-02
TypeNumberDevice NameCodeDateActions
510(k) K261867 Xpert Carba-RPOC2026-07-02 View
510(k) K250995 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01 View
510(k) K250996 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01 View
510(k) K243730 Xpert C. difficile/EpiOZN2025-02-28 View
510(k) K242109 Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX2025-01-15 View
510(k) K243625 Xpert MRSA/SA SSTINQX2024-12-18 View
510(k) K243405 Xpert vanANIJ2024-11-21 View
510(k) K243070 Xpert® SA Nasal CompleteNQX2024-10-25 View
510(k) K230440 Xpert® Xpress CoV-2 plusQQX2023-10-13 View
510(k) K231481 Xpert Xpress CoV-2/Flu/RSV plusQOF2023-08-17 View
510(k) K223046 Xpert® FII & FVNPR2023-02-15 View
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