FDA EUA Legal Language

• These test solutions have not been FDA cleared or approved;

 

• These tests have been authorized by FDA under an EUA for use by authorized laboratories;

• The antibody test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; 

• The RT-PCR tests have been authorized for the detection of SARS-CoV-2, not for any other viruses or pathogens; 

• These tests are 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.