Page: M+ Lite Ecotest COVID-19 IgG / IgM Rapid Test Device

From the manufacturer

 

  • To use this Product, the customer must be certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform waived, moderate or high complexity tests
  • The Product has not been FDA cleared or approved
  • The Product has been authorized by the FDA under an EUA for use by authorized laboratories
  • This test has been authorized only for the presence of IgM 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-19under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner