Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

66 results for "Cepheid"
1–24 of 66
Cleared Feb 20, 2026
Xpert Hemorrhagic Fever
K253653
Cepheid
Microbiology · 92d
Cleared Jan 16, 2026
Xpert GI Panel
K251721 · PCH
Cepheid
Microbiology · 226d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250996 · QOF
Cepheid
Microbiology · 30d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250995 · QOF
Cepheid
Microbiology · 30d
Cleared Feb 28, 2025
Xpert C. difficile/Epi
K243730 · OZN
Cepheid
Microbiology · 87d
Cleared Feb 21, 2025
Xpert® FII & FV
K250218 · NPR
Cepheid
Hematology · 28d
Cleared Jan 15, 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
K242109 · QQX
Cepheid
Microbiology · 180d
Cleared Jan 10, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K242071 · QOF
Cepheid
Microbiology · 178d
Cleared Dec 18, 2024
Xpert MRSA/SA SSTI
K243625 · NQX
Cepheid
Microbiology · 23d
Cleared Nov 21, 2024
Xpert vanA
K243405 · NIJ
Cepheid
Microbiology · 20d
Cleared Oct 25, 2024
Xpert® SA Nasal Complete
K243070 · NQX
Cepheid
Microbiology · 28d
Not Cleared Jun 27, 2024
Xpert HCV
DEN240016 · SBP
Cepheid
Microbiology · 72d
Cleared Oct 19, 2023
Xpert Xpress MVP
K231381 · PQA
Cepheid
Microbiology · 160d
Cleared Oct 13, 2023
Xpert® Xpress CoV-2 plus
K230440 · QQX
Cepheid
Microbiology · 234d
Cleared Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638 · NJR
Cepheid
Microbiology · 391d
Cleared Aug 17, 2023
Xpert Xpress CoV-2/Flu/RSV plus
K231481 · QOF
Cepheid
Microbiology · 86d
Cleared Feb 15, 2023
Xpert® FII & FV
K223046 · NPR
Cepheid
Hematology · 139d
Cleared Jun 07, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K221160 · PQA
Cepheid
Microbiology · 47d
Cleared May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · NJR
Cepheid
Microbiology · 535d
Cleared Feb 09, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · PQA
Cepheid
Microbiology · 209d
Cleared Oct 07, 2019
Cepheid Xpert Respiratory Control Panel
K190086 · PMN
Microbiologics, Inc.
Microbiology · 263d
Cleared Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and...
K190076 · OYX
Cepheid
Pathology · 254d
Cleared Jun 25, 2019
Cepheid Xpert SA Nasal Complete Control Panel
K191168 · PMN
Microbiologics, Inc.
Microbiology · 55d
Cleared Jun 20, 2019
Cepheid Xpert MRSA NxG Control Panel
K191172 · PMN
Microbiologics, Inc.
Microbiology · 50d