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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 ...
Business Wire

BioFire Submits 510(k) Application to FDA for FilmArray® Blood Culture Identification Test

SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc. today announced that it has submitted the FilmArray Blood Culture Identification (BCID) Panel to the U.S. Food and Drug Administration (FDA) ...
Business Wire

bioMérieux submits for FDA Clearance of the BIOFIRE ® FILMARRAY ® Pneumonia Panel

MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology ...
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

Qiagen reveals purchase price for Enzymatics buy; BioFire Diagnostics gets FDA blessing for updated PCR system;

> bioMérieux's BioFire Diagnostics division got an FDA nod and European approval for an updated version of its FilmArray PCR molecular diagnostic system, FilmArray 2.0.
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bioMérieux submits for FDA Clearance of the BIOFIRE FILMARRAY Pneumonia Panel

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology affiliate, has submitted to the Food and Drug Administration for ...