Flowflex™ COVID-19 Antigen Home Test
- Easy and Affordable
- Highly Accurate Nasal Swab Test
- Quick Results in 15 minutes
- Safe for children as young as 2 years old
- For use with and without symptoms
- (1) test per kit
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 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. The Flowflex COVID-19 Antigen Home Test does not require serial testing.
The Flowflex COVID-19 Antigen Home Test was compared to an FDA authorized molecular SARS-CoV-2 test. The Flowflex COVID-19 Antigen Home Test correctly identified 93% of positive specimens and 100% of negative specimens.
• Test Cassette
• Package Insert
• Extraction Buffer Tube
• Nasal Swab
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.
For more information on EUAs please CLICK HERE