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 ...
KENS

New test can determine if a patient has viral or bacterial infection in 15 minutes

CORPUS CHRISTI, Texas — When you head to the doctor's office, some of our local clinics now have a special test that can tell if you have a viral or bacterial infection in just 15 minutes. Physician's ...
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 ...
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 Information in the story may be outdated or superseded by additional information.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 ...
Firefighter Nation

BioFire Awarded Next Generation Diagnostics System Contract

SALT LAKE CITY, Utah (March 26, 2013) — BioFire Diagnostics, Inc. today announced that it has signed a competitive prototyping contract with the Department of the Army for Increment 1 of the Next ...
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 ...