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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 ...
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 ...
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 ...