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 ...
360Dx

BioMérieux Submits Updated Gastrointestinal Panels to FDA for 510(k) Review

The PCR-based panels detect up to 22 of the most common bacteria, viruses, and parasites associated with gastroenteritis.
FierceBiotech

BioFire Diagnostics wins FDA clearance for innovative GI panel

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.
Business Wire

BioFire Initiates Clinical Study for the FilmArray® Gastrointestinal Panel

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, ...
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 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) ...
Medical Xpress

Gastrointestinal viruses all but disappeared during COVID—but surged back two years on

To that end, they used a polymerase chain reaction (PCR) panel test called the BioFire FilmArray GI panel, which tests for 22 of the most common pathogens that cause diarrhea and analyzed about 18,000 ...