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Cepheid

FDA 510(k) & PMA Approved Devices — 56 products

Total Devices56
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K263120 Xpert Xpress CoV-2/Flu plusQOF2026-10-02 View
510(k) K261336 Xpert Respiratory PanelQOF2026-09-25 View
510(k) K261362 Xpert Hemorrhagic FeverQVR2026-08-07 View
510(k) K261867 Xpert Carba-RPOC2026-07-02 View
510(k) K253653 Xpert Hemorrhagic Fever2026-02-20 View
510(k) K251721 Xpert GI PanelPCH2026-01-16 View
510(k) K250996 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01 View
510(k) K250995 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01 View
510(k) K243730 Xpert C. difficile/EpiOZN2025-02-28 View
510(k) K250218 Xpert® FII & FVNPR2025-02-21 View
510(k) K242109 Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX2025-01-15 View
510(k) K242071 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-01-10 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) K231381 Xpert Xpress MVP; GeneXpert Xpress SystemPQA2023-10-19 View
510(k) K230440 Xpert® Xpress CoV-2 plusQQX2023-10-13 View
510(k) K222638 Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR2023-09-27 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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