Xpert Hemorrhagic Fever
Device Facts
| Record ID | K261362 |
|---|---|
| Device Name | Xpert Hemorrhagic Fever |
| Applicant | Cepheid |
| Product Code | QVR · Immunology |
| Decision Date | Aug 7, 2026 |
| Decision | SESE |
| Submission Type | Dual Track |
| Regulation | 21 CFR 866.4000 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens
