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FDA Warns Swedish IVD Manufacturer By Zachary Brennan - Published 10 October 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.

Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality

Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica