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 ...
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) ...
technologynetworks

BioFire Dx Initiates Clinical Study for the FilmArray™ Meningitis/Encephalitis Panel

Infection of the meninges surrounding the brain and spinal cord (meningitis), or of the brain (encephalitis) can have high mortality and morbidity rates depending on the source of infection. Acute ...
Reuters

Biomerieux says BioFire Receives FDA Clearance for FilmArray Torch

Feb 25 (Reuters) - Biomerieux Sa : * Biofire receives FDA clearance for Filmarray torch with Filmarray respiratory panel and submits special 510(K) applications for use with additional Filmarray ...
Reuters

Biomerieux unit BioFire receives FDA clearance for the FilmArray 2.0 system

The U.S. Treasury Department announced fresh sanctions on Wednesday on over 115 Iran-linked individuals, entities and vessels, in a sign the Trump administration is doubling down on its maximum ...