EUA Documentation

Statements And Conditions:

  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has not been FDA cleared or approved;
  • This test has been authorized only for the presence of lgM and IgG antibodies against 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)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
  • This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only)
  • Not for screening of donated blood