DOCUMENT
eNAT IFU
Copan eNAT® Molecular Collection and Preservation Medium
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For Use Under an Emergency Use Authorization (EUA) only. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens; and 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.
Full test runtime is 36 minutes. SARS-CoV-2 positive results available in as soon as 25 minutes with early assay termination.
Number of Tests: 10
Catalog #: XP3COV2/FLU/RSV-10