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 ...
Becker's Hospital Review

FDA approves 1st COVID-19 test cleared with CLIA waiver

The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...
BioWorld

FDA posts special controls for class II SARS-CoV-2 tests

The COVID-19 pandemic drove a large volume of in vitro diagnostic test efforts toward the SARS-CoV-2 virus, such as the Biofire respiratory panel by Biofire Diagnostics LLC, of Salt Lake City, a test ...
Morningstar

Narrow-Moat BioMerieux on Track for Record Year; BioFire Propelling Strength Through Pandemic

Narrow-moat BioMerieux reported strong third-quarter results, with reported growth of 21% (26.5% at constant currency) driven by 120% product line growth of BioFire respiratory panel 2.1, a syndromic ...
Reuters

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

* ‍FILMARRA RP2 REDUCES SAMPLE-TO-RESULT TIME TO ONLY 45 MINUTES WHILE ENHANCING PATHOGEN COVERAGE AND OVERALL SENSITIVITY * FILMARRAY RP2 REDUCES SAMPLE-TO-RESULT TIME TO ONLY 45 MINUTES WHILE ...