Warning: This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.