Business Wire

bioMérieux launches the BIOFIRE ® FILMARRAY ® Pneumonia Panels with FDA clearance and CE Marking

MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced the Food and Drug Administration (FDA) 510(k) ...
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) ...
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 ...
FierceBiotech

One-hour Ebola test from bioMérieux receives FDA emergency use authorization

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 ...
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 ...
Finanznachrichten

bioMérieux submits for FDA Clearance of the BIOFIRE FILMARRAY Pneumonia Panel

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology affiliate, has submitted to the Food and Drug Administration for ...
pharmaphorum

bioMérieux buys BioFire Diagnostics for $400m

France-based bioMérieux has acquired the privately held US company, BioFire Diagnostics Inc for $400 million, consolidating its position as a major player in infectious disease diagnostics. BioFire ...
Nasdaq

bioMérieux: BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

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

Dallas Hospital Had the Ebola Screening Machine That the Military Is Using in Africa

This story has been updated. The military is using an Ebola screening machine that could have diagnosed the Ebola cases in Texas far faster, but government guidelines prevent hospitals from using it ...
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 ...
BioWorld

Items Tagged with 'Biofire Filmarray'

PARIS – Europe has turned into the epicenter of the coronavirus pandemic, seeing more than 50% of the cases observed worldwide. In fact, whereas the COVID-19 pandemic has begun declining in China ...