Business Wire

BioFire Obtains CE IVD Mark for FilmArray® Blood Culture Identification Panel

SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc. announced today that it obtained the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its FilmArray Blood ...
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 ...
Pharmabiz

Idaho Technology gets US FDA clearance for expanded FilmArray RP

Idaho Technology, Inc.,(ITI) a privately held clinical diagnostics company, has received the US Food and Drug Administration (FDA) 510(k) clearance of five additional pathogens for its FilmArray ...
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: ...
National Institute for Health and Care Excellence

Integrated multiplex PCR tests for identifying gastrointestinal pathogens in people with suspected gastroenteritis (xTAG Gastrointestinal Pathogen Panel, FilmArray GI Panel and ...

July 2022: The guidance has been withdrawn because PCR tests now form part of standard care. Since the diagnostics guidance was published, expert advice suggests that clinical practice has moved on; ...
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 ...