Product Overview Product feature summary

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


• • This Test Is Authorized By FDA Under An Emergency Use Authorization (EUA) For Use By Authorized Laboratories Only. Authorized Laboratories Include 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 Test, When The Specimens Used Are Serum, Plasma, Or Venous Whole Blood. Testing Of Fingerstick Whole Blood Specimens Is Limited To Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. §263a, That Meet The Requirements To Perform High, Moderate Or Waived Complexity Tests. Testing Of Fingerstick Whole Blood Specimens Is Authorized For Use At The Point Of Care (POC), I.e., In Patient Care Settings Operating Under A CLIA Certificate Of Waiver, Certificate Of Compliance, Or Certificate Of Accreditation.


• • 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 Act, 21 U.S.C. § 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.

Specifications Product specifications and dimensions

• Brand
  Premier RightSign
• CLIA Classification
  CLIA Waived
• Item
  Test Kit
• Item Type
  COVID-19 IgG/IgM

Catalog Description As seen in our print catalog

A rapid chromatographic immunoassay for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood, serum or plasma, or fingerstick whole blood. The test is intended for use as an aid in identifying individuals with adaptive immune response to SARS-CoV-2, indicating recent or prior infection. CLIA waived.

ARTIST: Add these two lines to first part of note (NOTE field is too large)
This test has not been FDA cleared or approved.
This test is authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories only.