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.