510(k) clearance

Xpert® Hemorrhagic Fever Panel

FDA 510(k) source

510(k) number

K262971

Applicant

Cepheid

Decision date

Oct 30, 2026

Date received

Aug 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QVR

Device type

Multiplex Nucleic Acid Detection System For Biothreat Agents

Device class

Class II

Regulation

21 CFR 866.4000

Advisory committee

Immunology

Statement or summary

Summary

Third party

N

Location

Sunnyvale, CA, US