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FDA 510(k) & PMA Approved 器材 — 38 products

器材總數38
類別0
最新 FDA 裁決
類型編號器材名稱代碼日期操作
510(k) K261336 Xpert Respiratory PanelQOF2026-09-25 查看
510(k) K261362 Xpert Hemorrhagic FeverQVR2026-08-07 查看
510(k) K261867 Xpert Carba-RPOC2026-07-02 查看
510(k) K253653 Xpert Hemorrhagic Fever2026-02-20 查看
510(k) K251721 Xpert GI PanelPCH2026-01-16 查看
510(k) K250996 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01 查看
510(k) K250995 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-05-01 查看
510(k) K243730 Xpert C. difficile/EpiOZN2025-02-28 查看
510(k) K250218 Xpert® FII & FVNPR2025-02-21 查看
510(k) K242109 Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX2025-01-15 查看
510(k) K242071 Xpert Xpress CoV-2/Flu/RSV plusQOF2025-01-10 查看
510(k) K243625 Xpert MRSA/SA SSTINQX2024-12-18 查看
510(k) K243405 Xpert vanANIJ2024-11-21 查看
510(k) K243070 Xpert® SA Nasal CompleteNQX2024-10-25 查看
510(k) K231381 Xpert Xpress MVP; GeneXpert Xpress SystemPQA2023-10-19 查看
510(k) K230440 Xpert® Xpress CoV-2 plusQQX2023-10-13 查看
510(k) K222638 Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR2023-09-27 查看
510(k) K231481 Xpert Xpress CoV-2/Flu/RSV plusQOF2023-08-17 查看
510(k) K223046 Xpert® FII & FVNPR2023-02-15 查看
510(k) K221160 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA2022-06-07 查看
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