home covid test in Puerto Rico .FDA EUA CE ISO GMP SFC ETC
Product Description
The Quick Vue At-Home OTC COVID-19 Test is for FDA Emergency Use Authorization (EUA) Only
home covid test in Puerto Rico
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 SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the declaration that circumstances xist 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, home covid test in Puerto Rico Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1),
unless the declaration is terminated or authorization is revoked sooner.