The FREND COVID-19 Total Ab Test Has Not Been FDA Cleared Or Approved; The Test Has Been Authorized By FDA Under An EUA For Use By Authorized Laboratories (i.e., Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. §263a, That Meet The Requirements To Perform High Or Moderate Complexity Tests); The Test Has Been Authorized Only For The Presence Of Antibodies Against SARS-CoV-2, Not For Any Other Viruses Or Pathogens; And The 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)(1) Of The Federal Food, Drug, And Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.
This test is a fluorescence immunoassay (FIA) for the qualitative detection of total antibody to SARS-CoV-2 in human dipotassium EDTA plasma. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.