# Biofire Defense, LLC

- Location (FDA's records): Salt Lake City, UT
- FDA decisions: 10 (2017–2026): 8 510(k) clearances and 2 De Novo grants
- Product codes: PRD (3), PMN (2), QQX (2), QMV (2), QVR (1)
- Predicates its devices cite: 9 (7 its own); citations of its devices by later devices: 19 (7 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Maine Molecular Quality Controls, Inc.: 1 (https://510kreport.com/company/maine-molecular-quality-controls)
- Biofire Diagnostics, LLC: 1 (https://510kreport.com/company/biofire-diagnostics)

## Firms that cite its devices most
- Cepheid: 2 (https://510kreport.com/company/cepheid)
- Bd Integrated Diagnostic Solutions /: 2 (https://510kreport.com/company/bd-integrated-diagnostic-solutions)
- Mriglobal: 1 (https://510kreport.com/company/mriglobal)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Centers for Disease Control and Prevention: 1 (https://510kreport.com/company/centers-for-disease-control-and-prevention)
- Life Technologies Corporation: 1 (https://510kreport.com/company/life-technologies)
- T2biosystems, Inc.: 1 (https://510kreport.com/company/t2biosystems)
- Diasorin Molecular, LLC: 1 (https://510kreport.com/company/diasorin-molecular)

## Its most-cited devices
- K211079: BioFire COVID-19 Test 2 (2021), cited by 7
- K170883: FilmArray NGDS Warrior Panel (2017), cited by 4
- K202382: FilmArray Global Fever Panel External Control Kit (2020), cited by 2
- K220870: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (2022), cited by 2
- DEN200043: FilmArray Global Fever Panel (2020), cited by 2
- K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (2023), cited by 1

## Recent decisions
- K261475: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (Jul 17, 2026)
- K243822: BioFire Warrior Panel; BioFire Warrior Panel Control Kit (Mar 12, 2025)
- K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (Mar 22, 2023)
- K220870: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (Oct 20, 2022)
- K221460: BioFire COVID-19 Test 2 (Jul 25, 2022)
- K211079: BioFire COVID-19 Test 2 (Nov 1, 2021)
- K202382: FilmArray Global Fever Panel External Control Kit (Nov 20, 2020)
- DEN200043: FilmArray Global Fever Panel (Nov 20, 2020)

Source page: https://510kreport.com/company/biofire-defense