Now Authorized!

*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 certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, influenza B, and RSV, not for any other viruses or pathogens.

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.

**cobas® SARS-CoV-2 & Influenza A/B assay: If sample results indicate co-infection of SARS-CoV-2 with Influenza A or Influenza B and a positive influenza result would change clinical management, the sample should be re-tested with a second FDA cleared or EUA influenza test. cobas® SARS-CoV-2 assay: A negative result from an asymptomatic individual is presumptive. See package insert for details.