Medical Device Manufacturer · US , Salt Lake City , UT

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

28 submissions · 24 cleared · Since 2015

Recent clearances: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini, BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid, BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

Official Website

28

Total

24

Cleared

4

Denied

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

28 devices

1-12 of 28

Cleared Aug 14, 2025

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

Microbiology · 272d

Cleared Jan 16, 2025

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

Microbiology · 29d

Cleared Dec 20, 2024

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)...

Microbiology · 14d

Cleared Nov 07, 2024

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Microbiology · 90d

Cleared May 30, 2024

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

Microbiology · 30d

Cleared Mar 26, 2024

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

Microbiology · 187d

Cleared Apr 13, 2023

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

Microbiology · 29d

Cleared Mar 16, 2023

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Microbiology · 29d

Cleared Oct 27, 2022

FilmArray Pneumonia Panel plus

Microbiology · 59d

Not Cleared Apr 29, 2022

BioFire Joint Infection (JI) Panel

DEN200066 · QSN

Microbiology · 549d

Cleared Sep 22, 2021

FilmArray Pneumonia Panel

Microbiology · 26d

Not Cleared Mar 17, 2021

BioFire Respiratory Panel 2.1 (RP2.1)

DEN200031 · QOF

Microbiology · 302d