Cepheid - FDA 510(k) Cleared Devices
Recent clearances: Xpert Hemorrhagic Fever, Xpert GI Panel, Xpert Xpress CoV-2/Flu/RSV plus
60
Total
57
Cleared
3
Denied
FDA 510(k) Regulatory Record - Cepheid Microbiology ✕
56 devices
Cleared
Feb 20, 2026
Xpert Hemorrhagic Fever
Microbiology
92d
Cleared
Jan 16, 2026
Xpert GI Panel
Microbiology
226d
Cleared
May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
Microbiology
30d
Cleared
May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
Microbiology
30d
Cleared
Feb 28, 2025
Xpert C. difficile/Epi
Microbiology
87d
Cleared
Jan 15, 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
Microbiology
180d
Cleared
Jan 10, 2025
Xpert Xpress CoV-2/Flu/RSV plus
Microbiology
178d
Cleared
Dec 18, 2024
Xpert MRSA/SA SSTI
Microbiology
23d
Cleared
Nov 21, 2024
Xpert vanA
Microbiology
20d
Cleared
Oct 25, 2024
Xpert® SA Nasal Complete
Microbiology
28d
Not Cleared
Jun 27, 2024
Xpert HCV
Microbiology
72d
Cleared
Oct 19, 2023
Xpert Xpress MVP
Microbiology
160d
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