QVR · Multiplex Nucleic Acid Detection System For Biothreat Agents
Immunology · 21 CFR 866.4000 · Class 2
Overview
| Product Code | QVR |
|---|---|
| Device Name | Multiplex Nucleic Acid Detection System For Biothreat Agents |
| Regulation | 21 CFR 866.4000 |
| Device Class | Class 2 |
| Review Panel | Immunology |
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
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231336 | T2 Biothreat Panel | T2biosystems, Inc. | Sep 15, 2023 | SESE |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | Biofire Defense, LLC | Mar 22, 2023 | SESE |
Top Applicants
- T2biosystems, Inc. — 1 clearance
- Biofire Defense, LLC — 1 clearance
