Xpert MRSA/SA SSTI— 510(k) K243625

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K243625 for Xpert MRSA/SA SSTI, Substantially Equivalent on 2024-12-18. Applicant: Cepheid®. Device class: 2.

Clearance details

Applicant: Cepheid®
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2024-11-25
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQX

K243070 — Xpert® SA Nasal Complete2024-10-25
K191742 — ARIES MRSA Assay2019-09-25
K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System2019-04-25
K162444 — Xpert MRSA NxG2016-11-23
K142721 — cobas MRSA/SA Test2014-12-17

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
K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

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