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The VITROS Anti-SARS-CoV-2 IgG Quantitative, VITROS Anti-SARS-CoV-2 Total N Antibody, VITROS SARS-CoV-2 Antigen, VITROS Anti-SARS-CoV-2 Total and VITROS Anti-SARS-CoV-2 IgG Antibody Tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). They have been authorized by the FDA under an Emergency Use Authorization (EUA) and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate- or high-complexity tests.
The VITROS Antibody Tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. The VITROS Antigen Test has been authorized only for the detection of proteins from 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 diagnostic tests 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.