Biofire Defense, LLC
10 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (K261475) | Biofire Defense, LLC | 2026-07-17 |
| BioFire Warrior Panel; BioFire Warrior Panel Control Kit (K243822) | Biofire Defense, LLC | 2025-03-12 |
| 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 |
| BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (K220870) | Biofire Defense, LLC | 2022-10-20 |
| BioFire COVID-19 Test 2 (K221460) | Biofire Defense, LLC | 2022-07-25 |
| BioFire COVID-19 Test 2 (K211079) | Biofire Defense, LLC | 2021-11-01 |
| FilmArray Global Fever Panel (DEN200043) | Biofire Defense, LLC | 2020-11-20 |
| FilmArray Global Fever Panel External Control Kit (K202382) | Biofire Defense, LLC | 2020-11-20 |
| FilmArray NGDS Warrior Panel (K170883) | Biofire Defense, LLC | 2017-06-22 |
| FilmArray NGDS Warrior Panel (DEN160048) | Biofire Defense, LLC | 2017-02-14 |
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