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Zdrowie i gospodarka · 07/08/2019

FDA Revokes Emergency Use Authorization for Zika Virus Test

The FDA has revoked the Emergency Use Authorization for the ZIKV Detect 2.0 IgM Capture ELISA test, issued to InBios International, Inc., due to the test's reclassification as a Class II device under the FD&C Act.

Source: Federal Register — Food and Drug AdministrationOpen original release →