The SARS-CoV-2 molecular and antibody tests have not been FDA-cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. The molecular test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The antibody test has been authorized only for detecting the presence of antibodies against 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the. authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.