Xpert Xpress CoV-2/Flu plus— 510(k) K263333

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K263333 for Xpert Xpress CoV-2/Flu plus, Substantially Equivalent on 2026-10-22. Applicant: Cepheid®. Device class: 2.

Clearance details

Applicant: Cepheid®
Product code: Product code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2026-09-22
Decision date: 2026-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

K262938 — cobas eplex respiratory pathogen panel 32026-10-30
K263120 — Xpert Xpress CoV-2/Flu plus2026-10-02
K261336 — Xpert Respiratory Panel2026-09-25
K263054 — BIOFIRE Respiratory Panel 2.1 (RP2.1)2026-09-22
K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11

More clearances from Cepheid®

K262971 — Xpert® Hemorrhagic Fever Panel2026-10-30
K261362 — Xpert Hemorrhagic Fever2026-08-07
K261867 — Xpert Carba-R2026-07-02
K253653 — Xpert Hemorrhagic Fever2026-02-20
K251721 — Xpert GI Panel2026-01-16

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