Cepheid - FDA 510(k) Cleared Devices
60
Total
57
Cleared
3
Denied
Cepheid has 57 FDA 510(k) cleared microbiology devices. Based in Sunnyvale, US.
Latest FDA clearance: Feb 2026. Active since 2006.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Cepheid
60 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
Feb 21, 2025
Xpert® FII & FV
Hematology
28d
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
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