The Chembio DPP Zika IgM Assay System is a rapid test designed to detect IgM Antibodies to Zika virus in fingerstick whole blood, EDTA, venous whole blood, EDTA plasma and serum.
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*IMPORTANT: The test has not been FDA cleared or approved. The test has been authorized by FDA under an EUA for use by authorized laboratories. The test has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of the Zika virus and /or diagnosis of Zika virus infection under section 564(b)(1) of the Act 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.