US FDA – BioFire COVID-19 Test v1.1

• This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;

• This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

The EUA (Emergency Use Authorization) for the BioFire COVID-19 Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for SARS-CoV-2 in-house, providing results in approximately one hour.

Updated: May 24, 2022

EUA No: EUA200044

• Healthcare Provider Fact Sheet (PDF, 327 KB)
• Patient Fact Sheet (PDF, 223 KB)

Kits Available

Instructions for Use and Quick Guides are found in the table above

Software

Reporting