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. (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.