Devices intended to be used for the following purposes are classified as class D:
detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration;
detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;
determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.