Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Rule 1: Class D

• Transmissible agents • Blood, blood components, organs • High risk diseases • Determining infectious load of high-risk disease

E.g. Hepatitis B, C HIV 1

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Rule 2: Class D

• Blood grouping or tissue typing • Transplant or transfusion purposes • ABO, Rhesus, Kell, Kidd, Duffy systems

The Organisation for Professionals in Regulatory Affairs

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