Home use test kit

COVID-19for antigensSARS-COV-2

COVID-19 Antigen Test: Ease of use and Quick results “The Advin COVID-19 Antigen Test @ Home is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.” Features Multiple testing kit options Ease of use Quick results The Advin COVID-19 Antigen Test @Home is a non-prescription home test intended for the qualitative detection of SARS-CoV-2 in anterior nasal swab samples self-collected from individuals aged 14 years or older or adult-collected from individuals aged 2 years or older. 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. In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens.