Xpert Xpress CoV-2/Flu/RSV plus— 510(k) K250995

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K250995 for Xpert Xpress CoV-2/Flu/RSV plus, Substantially Equivalent on 2025-05-01. Applicant: Cepheid®. Device class: 2.

Clearance details

Applicant: Cepheid®
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2025-04-01
Decision date: 2025-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11
K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23

More clearances from Cepheid®

K261362 — Xpert Hemorrhagic Fever2026-08-07
K261867 — Xpert Carba-R2026-07-02
K253653 — Xpert Hemorrhagic Fever2026-02-20
K251721 — Xpert GI Panel2026-01-16
K250996 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.