CUE HEALTH INC. Cue Health COVID-19 Test (Home and OTC Use Only) C2020 10 Each - MDL-CXUC2020

COVID-19 Test Cartridge Pack, Home and OTC Use Only, Non-Returnable, Shelf Life Guarantee of at Least 30 Days

• Isothermal nucleic acid amplification assay intended for the qualitative detection of nucleic acid from the SARS-CoV-2 (the virus that causes COVID-19)
• Test is run using the Cue Health Monitoring System, CXUC0201 (sold separately)
• The Cue COVID-19 Test for Home and over-the-counter (OTC) Use is intended for use in adults (self-swabbing) or children ?2 years of age (swabbed by an adult)
• Non-returnable
• 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; and,
• 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.