The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms of COVID-19. Quickvue at-home otc covid-19 test kit in France The test is intended to be used twice over two to three days, with at least 24 hours and no more than 36 hours between tests.
Quickvue at-home otc covid-19 test kit in France This product has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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 authorization is terminated or revoked sooner.