The GenBody COVID-19 Ag test has not been FDA cleared or approved, but has been authorized by FDA under an EUA
for use
by authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2,
not for
any other viruses or pathogens; and, 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.
