Zika ELITe MGB Kit is authorized by the FDA under an EUA for use by authorized laboratories.
- Qualitative real-time PCR test to detect Zika virus in plasma and serum samples
- Indicated for use with the ELITe InGenius® system
- Easy sample-to-result solution
- Validated by major US reference laboratories
- Accurate and sensitive test to support patient management
Zika ELITe MGB Kit U.S.
- 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 detection of RNA from Zika virus and diagnosis of Zika virus infection, 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 the emergency use of in vitro diagnostic tests for detection of 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.