The BioFire® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 is now authorized under an EUA for use on both the BioFire 2.0 and BioFire Torch Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 detects 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes. BioFire also intends to submit the BioFire RP2.1 Panel to the FDA for de novo clearance on an accelerated timeline.
About Emergency Use Authorization:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.