Biofire Defense, LLC FDA Approvals

0 new drug approvals and 6 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	What it is	Route	Decided
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit510(k)Jul 17, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 17, 2026
BioFire Warrior Panel; BioFire Warrior Panel Control Kit510(k)Mar 12, 2025Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Mar 12, 2025
BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel510(k)Mar 22, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2023
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel510(k)Oct 20, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 20, 2022
BioFire COVID-19 Test 2510(k)Jul 25, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Jul 25, 2022
BioFire COVID-19 Test 2510(k)Nov 1, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 1, 2021