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. (vi) Other in vitro diagnostic medical devices (a) An in vitro diagnostic medical device shall be assigned to Class B, if sub-paragraphs (i) to (v) of paragraph 2 do not apply to it; or (b) It is a substance or device used for the assessment of the performance of an analytical procedure or a part thereof, without a quantitative or qualitative assigned value.
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