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 ...
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 ...
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 ...
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 ...
Reuters

Biomerieux affiliate submitted FilmArray Torch to the FDA

Jan 12 (Reuters) - Biomerieux SA : * BioFire Diagnostics, LLC, has submitted the FilmArray Torch to the U.S. Food and Drug Administration (FDA) for special 510(k) clearance for use with the FilmArray ...
KUTV

bioMérieux receives emergency-use consent for COVID-19 test production in Salt Lake City

(KUTV) — bioMérieux has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to ...
PE Hub

BioFire Diagnostics Ink $25M

BioFire Diagnostics Inc. has raised $25 million in new funding from New York-based Athyrium Opportunities Fund. The money will be used to help commercialize the company’s “FilmArray” diagnostic ...
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 ...
Finanznachrichten

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

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160111006622/en/ FilmArray® Torch instrument ...
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 ...