1 Test for Coronavirus (COVID-19) with results in about 45 minutes.
The BioFire® COVID-19 Test is a nested multiplexed RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider.
- 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 of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic 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.