technologynetworks

Idaho Technology Launches FilmArray(R) Respiratory Panel

Idaho Technology, Inc. announced the European launch of its FilmArray Respiratory Panel (FilmArray RP), a multiplex clinical diagnostic product that simultaneously detects 21 respiratory pathogens in ...
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 ...
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 ...
Medscape

FDA Approves Addition of 3 Bacteria to Respiratory Panel

May 18, 2012 — The US Food and Drug Administration (FDA) has given 510(k) clearance to the FilmArray Respiratory Panel to include testing for Bordetella pertussis, Mycoplasma pneumoniae, and ...
Firehouse

FDA Clears Idaho Technology's FilmArray Instrument

SALT LAKE CITY, UT - Idaho Technology, Inc. (ITI) announced today that the U.S. Food and Drug Administration has issued a 510(k) clearance for the FilmArray instrument and the FilmArray Respiratory ...
Reuters

Biomerieux' Filmarray Respiratory Panel EZ is CLIA waived by the FDA

* Filmarray RP EZ will be available on the US market only, Biofire anticipates commercial launch in November 2016 Source text for Eikon: Further company coverage: ...
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 ...