Product Overview Product feature summary

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


• • This Test Has Been Authorized By FDA Under An EUA For Use By Authorized Laboratories. Authorized Laboratories Are Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. õ263a, That Meet The Requirements To Perform High, Moderate Or Waived Complexity Tests. This Test 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 Detection Of Nucleic Acid From 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. õ 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.

Specifications Product specifications and dimensions

• Brand
  Cue Health
• CLIA Classification
  CLIA Waived
• For
  Use on Reader Only
• Item
  Test Cartridge
• Item Type
  COVID-19

Product Substitutes (1) This product is not available. See substitutes below:

Catalog Description As seen in our print catalog

A compact and portable device that automatically processes results from the Cue COVID-19 Test for Home and OTC Use (tests sold separately). Communicates test results digitally via Bluetooth to the Cue Health App on a mobile smart device (available on iOS and Android).