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Medical Devices / Regulatory Affairs

FDA Authorizes Two In Vitro Devices for Zika Detection

July 5, 2017

The FDA has issued two emergency use authorizations for in vitro diagnostic devices used to detect the Zika virus.

In February 2016, the HHS determined Zika presented significant potential for a public health emergency. In light of this, the FDA has issued emergency use authorizations for DiaSorin’s Liaison XL Zika Capture IgM Assay and Nanobiosym Diagnostics’ Gene-RADAR Zika Virus Test.

The agency also revoked its authorization for Roche’s LightMix Zika rRT-PCR Test, at Roche’s request.

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