Product Overview Product feature summary

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


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


• • This Test Has Been Authorized By FDA Under An EUA For Use By Laboratories Certified Under 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 IgM And IgG Antibodies Against SARSCoV-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 Federal Food, Drug And Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.

Specifications Product specifications and dimensions

• Brand
  Biotime
• CLIA Classification
  Moderately Complex
• Item
  Rapid Qualitative Test
• Item Type
  Sars-CoV-2 IgG/IgM