The parameters for classification of in vitro diagnostic medical devices as follows:— (i) In vitro diagnostic medical devices for detecting transmissible agents, etc. (a) An in vitro diagnostic medical device shall be assigned to Class D, if it is intended to be used for detecting the presence of, or exposure to, a transmissible agent that, — (1) is in any blood, blood component, blood derivative, cell, tissue or organ, in order to assess the suitability of the blood, blood component, blood derivative, cell, tissue or organ, as the case may be, for transfusion or transplantation; or (2) causes a life-threatening disease with a high risk of propagation. (b) An in vitro diagnostic medical device shall be assigned to Class C, if it is intended for use in, — (1) detecting the presence of, or exposure to, a sexually transmitted agent; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 88 of 248 (2) detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation (for example, Cryptococcus neoformans or Neisseria meningitidis); (3) detecting the presence of an infectious agent, where there is a significant risk that an erroneous result will cause death or severe disability to the individual or foetus being tested (for example, a diagnostic assay for Chlamydia pneumoniae, Cytomegalovirus or Methicillin-resistant Staphylococcus aureus); (4) pre-natal screening of women in order to determine their immune status towards transmissible agents such as immune status tests for Rubella or Toxoplasmosis; (5) determining infective disease status or immune status, where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient being tested (for example, Cytomegalovirus, Enterovirus or Herpes simplex virus in transplant patients); (6) screening for disease stages, for the selection of patients for selective therapy and management, or in the diagnosis of cancer; (7) human genetic testing, such as the testing for cystic fibrosis or Huntington's disease; (8) monitoring levels of medicinal products, substances or biological components, where there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening situation for the patient being tested (for example, cardiac markers, cyclosporin or prothrombin time testing); (9) management of patients suffering from a life-threatening infectious disease such as viral load of Human immunodeficiency virus or Hepatitis C virus, or genotyping and sub-typing Hepatitis C virus or Human immunodeficiency virus); or (10) screening for congenital disorders in the foetus such as Down's syndrome or spina bifida