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CUE™ Rapid Molecular COVID-19 Tests

CUE™ Rapid Molecular COVID-19 Tests

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The Cue™ Rapid Molecular COVID-19 Tests:

Cue's COVID-19 test is a molecular nucleic acid amplification test (NAAT) that detects the SARS-CoV-2 virus generic material. Molecular tests are more accurate than other methods such as antigen tests. The Cue COVID-19 Test uses isothermal nucleic acid amplification technology for the molecular amplification reaction that is an equivalent alternative amplification method to polymerase chain reaction (PCR). 

  • Simple nasal swab of lower nostrils.
  • Rapid results in 20 minutes.
  • Results delivered directly to the Cue Health App.
  • For Point of Care (POC) use or over the counter (OTC) sale.

Approved for home or over the counter (OTC) use. A CLIA number is not required to sell this OTC for home use.  A CLIA number IS required for professional use at the Point of Care by an appropriate health care practitioner.

**Requires CUE Health Reader to perform tests**

**See additional information and disclaimers in the links below.

Package Contents
10 pouches (tests) per pack
Each pouch contains 1 cartridge and 1 nasal swab

Key Disclaimer

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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 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 declaration is terminated or authorization is revoked sooner.

Refund Policy
The standard refund policy does not apply for COVID-19 rapid tests. All sales are final once goods are shipped and in transit with courier. NO EXCHANGES OR REFUNDS WILL BE MADE. 

Cue COVID-19 Test for Home/OTC Labelling
FDA EUA Letter
Instructions For Use
Fact Sheet For Individuals
Fact Sheet for Healthcare Professionals
CUE COVID-19 test FAQ

Cue COVID-19 Test for Professionals Labelling
FDA EUA Letter
Instructions For Use
Fact Sheet For Patients
Fact Sheet for Healthcare Professionals