This test, known as SalivaDirect™, has received Emergency Use Authorization (EUA) from the FDA.
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.
This test 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