Fastep COVID-19 IgG/IgM Antibody Rapid Test

Description

• Important Information
  The Fastep COVID-19 IgG/IgM Rapid Test Device by Assure Tech. has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. ?263a, to perform moderate or high complexity tests. 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 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.