QVR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Multiplex Nucleic Acid Detection System For Biothreat Agents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4000
- Medical specialty
- Immunology
- FDA definition
- 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
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Xpert Hemorrhagic Fever (K261362) | Cepheid | 2026-08-07 |
| T2 Biothreat Panel (K231336) | T2biosystems, Inc. | 2023-09-15 |
| BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (K213362) | Biofire Defense, LLC | 2023-03-22 |
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Every clearance here is in the API, with alerts when new ones post.