The Flowflex COVID-19 Antigen Home Test is an all-in-one test to determine COVID-19 status. This test can be used on children as young as two years of age and can be used whether symptoms are present or not.

The Flowflex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is authorized for non-prescription home use with selfcollected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older. The Flowflex COVID-19 Antigen Home Test does not differentiate between SARSCoV and SARS-CoV-2

The Flowflex COVID-19 Antigen Home Test Features:

• Easy-to-use nasal swab test
• Requires just 1 test*
• Can be used to test children as young as 2 years old
• For use with and without COVID-19 symptoms
• Accurate results in 15 minutes
• No need to send off to a lab to obtain results
• Compact packaging for “On-The-Go” testing

Other COVID-19 antigen home tests may require a 2nd test 2-3 days after the first.

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 proteins 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 IVDs 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.