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 ...
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 ...
KSL

Utah biotech firm BioFire earns first full FDA COVID-19 test approval

This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in ...
Pharmabiz

US FDA grants marketing authorization to BioFire’s Respiratory Panel 2.1 to detect SARS-CoV-2

The US Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification ...
Medindia

bioM rieux Receives Health Canada Approval for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

MONTREAL, Feb. 25, 2025 /CNW/ - bioM rieux, a world leader in the field of in vitro diagnostics, has achieved a significant milestone with the Health Canada approval of the BIOFIRE SPOTFIRE ...

WellStreet Urgent Care, bioMérieux celebrate 200,000 patients served through BIOFIRE® SPOTFIRE® tests in urgent care clinics across Georgia, Ohio and South Ca…

WellStreet Urgent Care, an expert in developing and scaling urgent care networks with health system partners, and bioMérieux, ...
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 ...
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 ...
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: BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

* BIOMÉRIEUX IS CURRENTLY MAKING EVERY EFFORT TO SCALE UP SUPPLY OF BIOFIRE(®) RP2.1 PANEL AT ITS PRODUCTION FACILITIES IN SALT LAKE CITY * TEST KITS WILL BE AVAILABLE FOR COMMERCIAL DISTRIBUTION IN ...
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 ...
Medindia

bioMérieux Receives Health Canada Approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel

MONTREAL, Feb. 25, 2025 /CNW/ - bioMérieux, a world leader in the field of in vitro diagnostics, has achieved a significant milestone with the Health Canada approval of the BIOFIRE® SPOTFIRE® ...