Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80— 510(k) K143302

Name: FDA 510(k) clearance K143302
Creator: U.S. Food and Drug Administration
Published: 2015-02-12

Substantially Equivalent

Cepheid

FDA 510(k) clearance K143302 for Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80, Substantially Equivalent on 2015-02-12. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code PEU
Device class: Class 2
Regulation: 21 CFR 866.3373
Advisory panel: Microbiology
Date received: 2014-11-17
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PEU

view all

DEN130032 — XPERT MTB/RIF ASSAY2013-07-25

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

Recalls naming K143302

K-number listed on FDA's recall record

Z-0724-2026 — Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.Class II·Ongoing·Cepheid·20251105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143302.

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