Tempus’ COVID-19 tests are either validated in accordance with FDA policies or have received an EUA authorization from FDA.
The EUA authorized test: has not been FDA cleared or approved; has been authorized by FDA under an EUA for use by the authorized laboratories; has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and 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 authorization is terminated or revoked sooner.
The SalivaDirect™ EUA authorized test: has not been FDA cleared or approved; has been authorized by FDA under an EUA for use by the authorized laboratories; has been authorized only for the collection and maintenance of saliva specimens as an aid in the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices 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.
Additional reference information for tests offered by Tempus: