Biofire Defense, LLC - FDA 510(k) Cleared Devices
9
Total
7
Cleared
2
Denied
Biofire Defense, LLC has 7 FDA 510(k) cleared medical devices. Based in Salt Lake City, US.
Latest FDA clearance: Mar 2025. Active since 2017. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Biofire Defense, LLC Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Biofire Defense, LLC
9 devices
Cleared
Mar 12, 2025
BioFire Warrior Panel
Microbiology
90d
Cleared
Mar 22, 2023
BioFire Global Fever Special Pathogens Panel
Microbiology
526d
Cleared
Oct 20, 2022
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global...
Microbiology
209d
Cleared
Jul 25, 2022
BioFire COVID-19 Test 2
Microbiology
67d
Cleared
Nov 01, 2021
BioFire COVID-19 Test 2
Microbiology
203d
Cleared
Nov 20, 2020
FilmArray Global Fever Panel External Control Kit
Microbiology
92d
Not Cleared
Nov 20, 2020
FilmArray Global Fever Panel
Microbiology
147d
Cleared
Jun 22, 2017
FilmArray NGDS Warrior Panel
Microbiology
90d
Not Cleared
Feb 14, 2017
FilmArray NGDS Warrior Panel
Microbiology
120d