Multiplex Nucleic Acid Detection System For Biothreat Agents
FDA product code QVR · Class II (moderate risk) · 21 CFR 866.4000 · Immunology
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
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | Cepheid | 08/07/2026SE |
| K231336 | T2 Biothreat PanelQVR · Traditional | T2biosystems, Inc. | 09/15/2023SE |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…QVR · Traditional | Biofire Defense, LLC | 03/22/2023SE |