In vitro diagnostic medical devices for blood grouping or tissue typing (a) Subject to clause (b), an in vitro diagnostic medical device shall be assigned to Class C, if it is intended to be used for blood grouping or tissue typing to ensure the immunological compatibility of any blood, blood component, blood derivative, cell, tissue or organ that is intended for transfusion or transplantation, as the case may be. (b) An in vitro diagnostic medical device referred to in clause (a) shall be assigned to Class D, if it is intended to be used for blood grouping or tissue typing according to the ABO system, the Duffy system, the Kell system, the Kidd system, the rhesus system (for example, HLA, Anti-Duffy, Anti-Kidd). (iii) In vitro diagnostic medical devices for self-testing (a) Subject to clause (b), an in vitro diagnostic medical device shall be assigned to Class C, if it is intended to be used for self-testing. (b) An in vitro diagnostic medical device referred to in clause (a) shall be assigned to Class B, if it is intended to be used to obtain, — (1) test results that are not for the determination of a medicallycritical status; or (2) preliminary test results which require confirmation by appropriate laboratory tests. (iv) In vitro diagnostic medical devices for near-patient testing An in vitro diagnostic medical device shall be assigned to Class C, if it is to be used for near-patient testing in a blood gas analysis or a blood glucose determination.