Product Overview Product feature summary

• • This Product Has Not Been FDA Cleared Or Approved And;


• • This Test Has Been Authorized By FDA Under An Emergency Use Authorization (EUA) For Use By Laboratories Certified Under The CLIA That Meet The Requirements To Perform Moderate, High Or Waived Complexity Tests. This Product 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.


• • The Emergency Use Of This Product 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. § 360bbb-3(b)(1), Unless The Declaration Is Terminated Or Authorization Is Revoked Sooner.


• • This Product Has Been Authorized Only For The Detection Of Proteins From SARS-CoV-2, Not For Any Other Viruses Or Pathogens.

Specifications Product specifications and dimensions

• Brand
  CareStart
• CLIA Classification
  CLIA Waived
• Item
  Test Kit
• Item Type
  COVID-19 Antigen
• Quantity
  20/Box