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FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process americanpharmaceuticalreview
March 24, 2021
The U.S. Food and Drug Administration (FDA) 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 ...
Streck Cell-Free DNA BCT Receives FDA De Novo Clearance americanpharmaceuticalreview
September 18, 2020
Streck Cell-Free DNA BCT received U.S. Food and Drug Administration (FDA) De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay.