Product Overview Product feature summary

• This product is an automated analyzer for performing in vitro diagnostic tests, meaning the tests are performed outside the body.

• This test is for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens collected with the Cue Sample Wand. It is intended for use in adults (self-swabbing) or children ages two and older (swabbed by an adult), with or without symptoms or other epidemiological reasons to suspect COVID-19. The test is for home and OTC use, and it is authorized for use without a prescription.

• This product may only be used with the Cue COVID-19 Test Cartridge Pack and the Cue Health App on a mobile smart device.

• This product, used with the Cue COVID-19 Test Cartridge Pack and the Cue Health App, 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 the authorization is revoked sooner.

Specifications Product specifications and dimensions

• Brand
  Cue Health
• Item
  System
• Item Type
  Monitoring
• Quantity
  Each

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

Catalog Description As seen in our print catalog

The Cue™ COVID-19 Test is a molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. Intended for use in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. Authorized for nonprescription home use. Utilizes isothermal nucleic amplification technology. Must be used with the Cue Health Monitoring System (Cue Cartridge Reader) and the Cue Health Mobile App.