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The QIAstat-Dx Analyzer and the QIAstat-Dx Respiratory Panel are intended for in vitro diagnostic use.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for in vitro diagnostic use.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and
This 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 Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declarations is terminated or authorization is revoked sooner.