bioMérieux: De Novo authorision for BioFire RP2.1
(CercleFinance.com) - bioMérieux has announced that its subsidiary BioFire Diagnostics has received De Novo authorisation from the US FDA for the Biofire 2.
1 respiratory panel (RP2.1), which detects 22 viral and bacterial pathogens, including SARS-CoV-2.
This panel is the first diagnostic test for the virus that causes Covid-19 to be approved by the FDA after completing a regular approval process, excluding emergency use authorization (EUA).
The in-vitro diagnostics specialist points out that its Biofire RP2.1 test gives results in approximately 45 minutes from a naso-pharyngeal swab sample.
Copyright (c) 2021 CercleFinance.com. All rights reserved.
1 respiratory panel (RP2.1), which detects 22 viral and bacterial pathogens, including SARS-CoV-2.
This panel is the first diagnostic test for the virus that causes Covid-19 to be approved by the FDA after completing a regular approval process, excluding emergency use authorization (EUA).
The in-vitro diagnostics specialist points out that its Biofire RP2.1 test gives results in approximately 45 minutes from a naso-pharyngeal swab sample.
Copyright (c) 2021 CercleFinance.com. All rights reserved.