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Medical Devices / Regulatory Affairs

FDA Authorizes Two In Vitro Devices for Zika Detection

July 5, 2017
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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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