Health
FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process – FDA.gov
BioFire Diagnostics LLC granted De Novo for its BioFire Respiratory Panel 2.1.
For Immediate Release:
March 17, 2021
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 identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing…
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