Xpert® Hemorrhagic Fever Panel— 510(k) K262971

Substantially Equivalent

Cepheid

FDA 510(k) clearance K262971 for Xpert® Hemorrhagic Fever Panel, Substantially Equivalent on 2026-10-30. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Product code QVR
Device class: Class 2
Regulation: 21 CFR 866.4000
Advisory panel: Immunology
Date received: 2026-08-26
Decision date: 2026-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QVR

K261362 — Xpert Hemorrhagic Fever2026-08-07
K231336 — T2 Biothreat Panel2023-09-15
K213362 — BioFire Global Fever Special Pathogens Panel +1 more2023-03-22

More clearances from Cepheid

K263333 — Xpert Xpress CoV-2/Flu plus2026-10-22
K263120 — Xpert Xpress CoV-2/Flu plus2026-10-02
K261336 — Xpert Respiratory Panel2026-09-25
K261867 — Xpert Carba-R2026-07-02
K253653 — Xpert Hemorrhagic Fever2026-02-20

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