US FDA Issues Two EUAs For Abbott, ELITechGroup Zika Tests

FDA recently issued two Emergency Use Authorizations to two different device firms for their molecular-based Zika virus tests, including for Abbott Molecular's RealTime Zika Assay, and for ELITechGroup's Zika ELITe MGB Kit U.S.

US FDA recently granted Emergency Use Authorizations to two molecular-based Zika virus tests from Abbott Molecular Inc. and from ELITechGroup Inc. Molecular Diagnostics. The agency, which began granting EUAs for the Zika virus earlier this year, now lists a total of 14 different assays on its Emergency Use Authorizations webpage that can be used to detect the Zika virus.

On Dec. 9, FDA issued an EUA for emergency use of ELITechGroup Inc.'s Zika ELITe MGB Kit U.S., designed for...

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