COVID-19 Test

Flowflex Covid-19 Antigen Home Test.
Nasal swab test for use with and without symptoms in ages 2 and up. Does not require serial screening.

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.

The test is authorized for non-prescription home use with self-collected 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
Excellent performance when compared to an FDA-authorized molecular SARS-CoV-2 test.

The product has not been FDA cleared or approved but has been authorized by FDA under a EUA.
The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
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 soon.