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Biofire Diagnostics, LLC FDA Approvals
0 new drug approvals and 12 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini510(k)Aug 14, 2025Microbiology |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid510(k)Jan 16, 2025Microbiology |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))510(k)Dec 20, 2024Microbiology |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel510(k)Nov 7, 2024Microbiology |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini510(k)May 30, 2024Microbiology |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel510(k)Mar 26, 2024Microbiology |
| BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini510(k)Apr 13, 2023Microbiology |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel510(k)Mar 16, 2023Microbiology |
| FilmArray Pneumonia Panel plus510(k)Oct 27, 2022Pathology |
| BioFire Joint Infection (JI) Panel510(k)Apr 29, 2022Microbiology |
| FilmArray Pneumonia Panel510(k)Sep 22, 2021Microbiology |
| BioFire Respiratory Panel 2.1 (RP2.1)510(k)Mar 17, 2021Microbiology |