Cepheid - FDA 510(k) Cleared Devices

Cleared Feb 20, 2026

Xpert Hemorrhagic Fever

K253653

Microbiology · 92d

Cleared Jan 16, 2026

Xpert GI Panel

K251721 · PCH

Microbiology · 226d

Cleared May 01, 2025

Xpert Xpress CoV-2/Flu/RSV plus

K250995 · QOF

Microbiology · 30d

Cleared May 01, 2025

Xpert Xpress CoV-2/Flu/RSV plus

K250996 · QOF

Microbiology · 30d

Cleared Feb 28, 2025

Xpert C. difficile/Epi

K243730 · OZN

Microbiology · 87d

Cleared Jan 15, 2025

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

K242109 · QQX

Microbiology · 180d

Cleared Jan 10, 2025

Xpert Xpress CoV-2/Flu/RSV plus

K242071 · QOF

Microbiology · 178d

Cleared Dec 18, 2024

Xpert MRSA/SA SSTI

K243625 · NQX

Microbiology · 23d

Cleared Nov 21, 2024

Xpert vanA

K243405 · NIJ

Microbiology · 20d

Cleared Oct 25, 2024

Xpert® SA Nasal Complete

K243070 · NQX

Microbiology · 28d

Not Cleared Jun 27, 2024

Xpert HCV

DEN240016 · SBP

Microbiology · 72d

Cleared Oct 19, 2023

Xpert Xpress MVP

K231381 · PQA

Microbiology · 160d