Zdrowie i gospodarka · 04/10/2005

FDA Classifies AFP-L3% Immunological Test Systems as Class II Devices with Special Controls

The Food and Drug Administration (FDA) has classified AFP-L3% immunological test systems into Class II, requiring special controls to ensure the device's safety and effectiveness, as outlined in the new guidance document 'Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems'.