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 ...
Medscape

FDA OKs Multipathogen Nucleic Acid Test for CNS Infections

The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous ...
Nasdaq

bioMérieux submits enhanced BIOFIRE® BCID2 Panel for FDA clearance

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 ...
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 ...
usace.army.mil

USAMMDA Announces Availability of FDA-Approved Diagnostic Test Panel for Four Infectious Diseases

Recently, 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.
News Medical

FDA permits marketing of first CSF nucleic acid-based test for detection of multiple pathogens

The U.S. Food and Drug Administration today allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central ...