WebSafeguarding Humanity. At BioFire Defense we deliver a fully integrated suite of biological agent identification products, including BioFire ® FilmArray ® and RAZOR ® Mk II Systems to the biodefense and first … WebMar 17, 2024 · 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 ...
510(k) Premarket Notification
WebThe BioFire RP2.1 served as a comparison during the trial; its specific assays for the presence of SARS-CoV-2 differ from those in BioFire COVID-19 Test 2, though the principles of the tests are the same. This study demonstrated that the BioFire COVID-19 Test 2 is highly sensitive and specific for the presence of SARS-CoV-2 RNA/nucleic acid. WebEUA for the BIOFIRE® RP2.1 panel and CE-marked of the BIOFIRE® RP2.1plus panel. Emergency use authorization (EUA) from the FDA for the BIOFIRE® RP2.1 panel covering 22 pathogens responsible for respiratory infections, including SARS-CoV-2. ... FDA 510(k) clearance for the BacT/ALERT® VIRTUO™ automated blood culture system. green building company huddersfield
BioFire Dx Receives First FDA Marketing Clearance for SARS
WebThe BioFire RP2.1/RP2.1 plus Control Panel was evaluated on the FilmArray 2.0 instrument. I. Device Description: BioFire RP2.1/RP2.1plus Control Panel M441, P/N … WebThe BioFire® COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs. In the case of the RP2.1, an additional 21 viral and bacterial pathogens can be detected. Both tes … Webthe BioFire RP2.1 may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be … green building competition