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 ...
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 Information in the story may be outdated or superseded by additional information.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 ...
usace.army.mil

USAMMDA Announces FDA 510 (k) Clearance of Rapid Diagnostic Test for COVID-19

The U.S. Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care Project Management Office, along with its commercial partner BioFire Defense, announced the U.S. Food and ...
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 ...
The Digital Universe

Utah company develops first fully FDA-authorized COVID-19 test

A BYU life science student works with COVID-19 samples. A Utah lab called BioFire developed the first fully FDA-approved COVID-19 test. (Todd Jackson) A biotech company from Utah has developed the ...
Yahoo Finance

Should Altesa BioSciences’ Use of SPOTFIRE Shift bioMérieux’s (ENXTPA:BIM) Diagnostic Market Position?

On September 9, 2025, Altesa BioSciences announced a partnership with bioMérieux to use the BIOFIRE SPOTFIRE respiratory diagnostic platform as the primary point-of-care tool in its upcoming Phase 2B ...
Yahoo Finance

Private GP Clinic Sloane Street Surgery Marks One Year of Same-Day Diagnostic Testing, Transforming Infection Care for London Patients

Sloane Street Surgery's BioFire testing provides same-day identification of infections, allowing faster, safer and more targeted treatment London, United Kingdom--(Newsfile Corp. - November 24, 2025) ...
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 ...