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 ...
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 ...
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

BIOFIRE Respiratory Panel 2.1 plus with SARS-CoV-2 is CE marked

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that the BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) is CE marked. The BIOFIRE Respiratory Panel 2.1 ...
FierceBiotech

Qiagen reveals purchase price for Enzymatics buy; BioFire Diagnostics gets FDA blessing for updated PCR system;

> bioMérieux's BioFire Diagnostics division got an FDA nod and European approval for an updated version of its FilmArray PCR molecular diagnostic system, FilmArray 2.0.
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 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, ...
Reuters

Biomerieux receives FDA clearance for BioFire’s FilmArray Respiratory Panel 2 (RP2)

* ‍FILMARRA RP2 REDUCES SAMPLE-TO-RESULT TIME TO ONLY 45 MINUTES WHILE ENHANCING PATHOGEN COVERAGE AND OVERALL SENSITIVITY * FILMARRAY RP2 REDUCES SAMPLE-TO-RESULT TIME TO ONLY 45 MINUTES WHILE ...
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 ...
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 ...
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 ...
Finanznachrichten

bioMérieux: BIOFIRE Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 Obtains De Novo FDA Authorization

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary specialized in molecular syndromic infectious disease testing, has ...