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 ...
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 ...
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 ...
Business Wire

First of 3 Diagnostic Tests for SARS-CoV-2 Coronavirus Available from bioMérieux

MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, is announcing the forthcoming launch of 3 different tests to ...
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 ...
Nasdaq

bioMérieux submits enhanced BIOFIRE® BCID2 Panel for FDA clearance

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 Information in the story may be outdated or superseded by additional information.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

FDA authorizes first COVID test via traditional review pathway

The US Food and Drug Administration (FDA) on Wednesday authorized the first diagnostic for COVID-19 using a traditional review process, paving the way for more tests to gain clearance through the ...
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 ...
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 ...