Authorized by the FDA under a EUA for use by authorized laboratories.
This test has not been FDA cleared or approved
This test is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of in vitro diagnostic tests for detection and/or diagnosis of COVID-19
under Section 564(b)(1) of the Act,21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.