Product Overview Product feature summary

• • This Test Has Not Been FDA Cleared Or Approved;


• • This Test Has Been Authorized By FDA Under An EUA.


• • Testing Is Limited To Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C §263a, That Meet Requirements To Perform Moderate Or High Complexity Tests.


• • This Test Has Been Authorized Only For The Presence Of 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)(1) Of The Food, Drug And Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner

Specifications Product specifications and dimensions

• Brand
  FREND
• CLIA Classification
  Moderately Complex
• For
  FREND
• Item
  Reagent Cartridge
• Item Type
  COVID-19 TOTAL Antibody
• Packaging
  20 Cards

Catalog Description As seen in our print catalog

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.