Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System— 510(k) K212213

Name: FDA 510(k) clearance K212213
Creator: U.S. Food and Drug Administration
Published: 2022-02-09

Substantially Equivalent

Cepheid

FDA 510(k) clearance K212213 for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System, Substantially Equivalent on 2022-02-09. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code PQA
Device class: Class 2
Regulation: 21 CFR 866.3975
Advisory panel: Microbiology
Date received: 2021-07-15
Decision date: 2022-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PQA

view all

K260021 — cobas® BV/CV2026-07-16
K243725 — BD Vaginal Panel2024-12-19
K243345 — Aptima BV Assay; Aptima CV/TV Assay2024-11-25
K231381 — Xpert Xpress MVP; GeneXpert Xpress System2023-10-19
K223653 — BD Vaginal Panel2023-03-06

More clearances from Cepheid

view all

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.