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 ...
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 ...
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 ...
Finanznachrichten

bioMérieux submits enhanced BIOFIRE BCID2 Panel for FDA clearance

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 ...
News Medical

FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway

Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and ...
Yahoo Finance

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 ® ...
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 ...
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 Information in the story may be outdated or superseded by additional information.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 ...
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: 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 ...
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 ...