The Assure COVID-19 IgG/IgM Rapid Test Has Not Been Cleared Or Approved By FDA. FDA Has Authorized The Test Under An Emergency Use Authorization, For Use By authorized Laboratories. Authorized Laboratories Are Laboratories That Are 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 And They May Use The Test On The Following Sample Types: Human Venous Whole Blood Samples, Serum, Plasma, And Fingerstick Whole Blood. Authorized Laboratories Also Include Point Of Care, In Patient Care Settings Operating Under A CLIA Certificate Of Waiver, Certificate Of Compliance, Or Certificate Of Accreditation, When Fingerstick Whole Blood Samples Are Used).

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; And 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 Federal Food, Drug And Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.