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FDA Classifies Zika Virus Serological Reagents
May 29, 2025
WASHINGTON, May 29 (TNSFR) -- The Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, has issued a final order classifying the Zika virus serological reagents into class II with special controls.

This action, effective May 29, 2025, aims to provide a reasonable assurance of the device's safety and effectiveness, while also enhancing patient access to beneficial innovative medical devices by reducing regulatory burdens. The classifica . . .

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