Information Provided By The Manufacturer
Flowflex™ COVID-19 Antigen Home Test Kit
Flowflex™ COVID-19 Antigen Home Test Kit is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
Qualitative detection of the nucleocapsid 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.
The Flowflex™ COVID-19 Antigen Home Test is authorized by FDA under an Emergency Use Authorization (EUA).
Disclaimer
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 SARSCoV-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..
Bulk Orders may require longer shipping times than those listed.
No warranty information available.
