home covid test in Costa Rica

Product Description

The QuickVue At-Home OTC COVID-19 Test meets all accuracy requirements as defined by the FDA. home covid test in Costa Rica  The performance was measured during a clinical study that compared the QuickVue At-Home OTC COVID-19 Test results to an FDA Emergency Use Authorized high sensitivity PCR (molecular) test. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for both symptomatic and asymptomatic individuals were 83.5% and 99.2%, respectively.

This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). home covid test in Costa Rica  This product has been authorized only 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 the declaration is terminated or authorization is revoked sooner.