510(k) K261362

Device

Xpert Hemorrhagic Fever

Applicant

Cepheid

510(k) number

K261362

Product code

QVR

Decision

Substantially Equivalent (SESE)

Decision date

2026-08-07

Date received

2026-04-27

Regulation

866.4000

Classification name

Multiplex Nucleic Acid Detection System For Biothreat Agents

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Dual Track

Statement or summary

Summary

Third party reviewed

N