Biofire Defense, LLC
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories5
Latest FDA decision2026-07-17
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | PMN | 2026-07-17 | View |
| 510(k) | K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | PRD | 2025-03-12 | View |
| 510(k) | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | QVR | 2023-03-22 | View |
| 510(k) | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | QMV | 2022-10-20 | View |
| 510(k) | K221460 | BioFire COVID-19 Test 2 | QQX | 2022-07-25 | View |
| 510(k) | K211079 | BioFire COVID-19 Test 2 | QQX | 2021-11-01 | View |
| 510(k) | K202382 | FilmArray Global Fever Panel External Control Kit | PMN | 2020-11-20 | View |
| 510(k) | K170883 | FilmArray NGDS Warrior Panel | PRD | 2017-06-22 | View |
No matching devices.