Medical Device Manufacturer · US , Salt Lake City , UT

Biofire Defense, LLC - FDA 510(k) Cleared Devices

10 submissions · 8 cleared · Since 2017

Recent clearances: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit, BioFire Warrior Panel, BioFire Global Fever Special Pathogens Panel

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10

Total

8

Cleared

2

Denied

FDA 510(k) Regulatory Record - Biofire Defense, LLC Microbiology ✕

10 devices

1-10 of 10

Cleared Jul 17, 2026

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

Microbiology · 73d

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

DEN200043 · QMV

Microbiology · 147d

Cleared Jun 22, 2017

FilmArray NGDS Warrior Panel

Microbiology · 90d

Not Cleared Feb 14, 2017

FilmArray NGDS Warrior Panel

DEN160048 · PRD

Microbiology · 120d