Posted by Michael Wonder on 17 Mar 2021
FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
17 March 2021 - BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorisation using the de novo review pathway.
Today, the U.S. FDA granted marketing authorisation of the BioFire Respiratory Panel 2.1, a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of COVID-19 and other respiratory tract infections.
