Biofire Diagnostics FDA Approvals

0 new drug approvals and 2 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 Respiratory Panel 2.1 (RP2.1)510(k)Sep 22, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Sep 22, 2026
BIOFIRE SPOTFIRE Respiratory (R) Panel510(k)Feb 3, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Feb 3, 2023