usace.army.mil

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 Special 510(k) Application to the FDA for the use of FilmArray ® Torch, the New High Throughput FilmArray ® System with FilmArray ® Respiratory Panel

MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular ...
KUTV

bioMérieux receives emergency-use consent for COVID-19 test production in Salt Lake City

(KUTV) — bioMérieux has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to ...
KSL

Utah biotech firm BioFire earns first full FDA COVID-19 test approval

This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in ...
Kiii3 News

New test can determine if a patient has viral or bacterial infection in 15 minutes

CORPUS CHRISTI, Texas — When you head to the doctor's office, some of our local clinics now have a special test that can tell if you have a viral or bacterial infection in just 15 minutes. Physician's ...