Fornitore: ABLE DIAGNOSTICS INC
FlowFlex Covid-19 Antigen Home Test, Includes 1 Tests
Descrizione
- Flowflex Covid-19 Antigen Home Test
- DOES NOT require Serial Screening
- Nasal Swab Test
- For use with and without symptoms
- For ages 2 and up
Features / Benefits
- 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
- 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
- Product has not been FDA cleared or approved but has been authorized by FDA under an EUA
- 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 soone

