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. Illustration: Anticoagulant monitoring, diabetes management, and testing for C-reactive protein and Helicobacter pylori. (v) In vitro diagnostic medical devices used in in vitro diagnostic procedures An in vitro diagnostic medical device shall be assigned to Class A: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 90 of 248 (1) if it is a reagent or an article which possesses any specific characteristic that is intended by its product owner to make it suitable for an in vitro diagnostic procedure related to a specific examination; (2) an instrument intended specifically to be used for an in vitro diagnostic procedure; or (3) a specimen receptacle.