SALT LAKE CITY, UT - Idaho Technology, Inc. (ITI) announced today that the U.S. Food and Drug Administration has issued a 510(k) clearance for the FilmArray instrument and the FilmArray Respiratory ...
On July 28, BioFire sponsored a webinar titled “The Clinical IMPACT of the FilmArray GI Panel.” The webinar featured Kimberle Chapin, MD, DABMM, FCAP, Director of Microbiology and ID Molecular ...
SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc., recently announced that it has commenced clinical and analytical studies to evaluate the company’s FilmArray Gastrointestinal (GI) Panel, ...
SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc. announced today that it obtained the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its FilmArray Blood ...
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.
The U.S. Food and Drug Administration has given a temporary thumbs up to Ebola test FilmArray BioThreat-E from BioFire Defense, a bioMérieux company. The test offers results in one hour rather than ...
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 ...
Background. Molecular syndromic diagnostic panels can enhance pathogen identification in the approximately 2–4 billion episodes of acute gastroenteritis that occur annually worldwide. However, the ...
Idaho Technology, Inc. announced the European launch of its FilmArray Respiratory Panel (FilmArray RP), a multiplex clinical diagnostic product that simultaneously detects 21 respiratory pathogens in ...
Jan 12 (Reuters) - Biomerieux SA : * BioFire Diagnostics, LLC, has submitted the FilmArray Torch to the U.S. Food and Drug Administration (FDA) for special 510(k) clearance for use with the FilmArray ...