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Biofire Diagnostics, LLC (Biomerieux) 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
BIOFIRE FILMARRAY Tropical Fever Panel510(k)Dec 5, 2024Microbiology
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)510(k)Nov 6, 2024Pathology

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