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 ...
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 ® ...
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 ...
Reuters

Biomerieux receives FDA clearance for BioFire’s FilmArray Respiratory Panel 2 (RP2)

British finance minister Rachel Reeves plans to announce next week that she will postpone a planned rise in tax on motor fuel that is due to take place in ‌September, the Sun newspaper reported late ...
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 ...
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 ...
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 ...
The Globe and Mail

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

Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B virus, Parainfluenza virus, Respiratory syncytial virus and Coronavirus SARS-CoV-2. A world leader in the field of in vitro diagnostics ...