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USAMMDA Announces FDA 510 (k) Clearance of Rapid Diagnostic Test for COVID-19

The U.S. Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care Project Management Office, along with its commercial partner BioFire Defense, announced the U.S. Food and ...
Yahoo Finance

bioMérieux Unveils its BIOFIRE® SPOTFIRE® Molecular Testing Solution for the Pharmaceutical Industry, Redefining Rapid Mycoplasma Testing

MARCY-L'ÉTOILE, France, April 9, 2026 /PRNewswire/ -- bioMérieux, a world leader in the field of in vitro diagnostics, announces the launch of BIOFIRE ® SPOTFIRE ® for pharmaceutical industries, where ...
Business Wire

bioMérieux: BIOFIRE ® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

The BIOFIRE ® FILMARRAY ® range has the largest infectious disease pathogen menu commercially available, composed of: BIOFIRE ® Respiratory Panel (RP, RP2 and RP2 plus), identifying between 20 and 22 ...
FierceBiotech

BioMérieux's BioFire sets course for GI panel FDA clearance

Just a month out from being bought by French giant bioMérieux, BioFire Diagnostics took its FilmArray diagnostic system's new gastrointestinal option to the FDA for clearance, which the newly united ...
FierceBiotech

BioFire Diagnostics wins FDA clearance for innovative GI panel

BioFire Diagnostics won 510(k) clearance for its gastrointestinal panel for infectious diarrhea, following in the footsteps of the company's acquisition by French diagnostic giant bioMérieux.