The in vitro diagnostic reagents referred to in the "In Vitro Diagnostic Reagents Registration Management Measures (for Trial Implementation)" refers to the in vitro diagnostic reagents that are managed according to the medical devices, including the in vitro diagnostic reagents, including those that can be used alone or in combination with the instruments, apparatuses, equipments, or systems in the process of prevention, diagnosis of the disease, therapeutic monitoring, prognostic observation, evaluation of the state of health as well as prediction of the hereditary diseases.
Reagents, kits, calibrators (substances), quality control products (substances), etc., used for in vitro testing of human samples (various body fluids, cells, tissue samples, etc.). According to the degree of risk of the product, in vitro diagnostic reagents are categorized into Category III, Category II and Category I products in that order.
The third category of products: reagents related to the detection of pathogenic pathogens antigens, antibodies, and nucleic acids; reagents related to blood grouping and tissue mapping; reagents related to human gene detection; reagents related to genetic diseases; reagents related to the detection of narcotic drugs, psychotropic drugs, and toxic drugs for medical use; and reagents related to detection of therapeutic drug action targets.
Extended information:
The development of the in vitro diagnostic reagent industry is extremely similar to that of the home appliance industry in the early 1990s of the last century: on the one hand, there is a large market, and on the other hand, the monopoly of the imported reagents and diagnostic instruments is being broken and constrained by national products. broken and constrained." This is a summary of the current situation of in vitro diagnostic reagent development in China.
The overall development of China's in vitro diagnostic reagent industry shows a kind of characteristics of a large developing country, that is, the market is big and the market potential is even bigger. China has more than 18,000 hospitals, more than 300 blood stations, at the same time, thousands of medical examination centers and hundreds of independent laboratories are springing up, and some independent medical testing laboratories are also in the ascendant, which provides a broad market space for the development of in vitro diagnostic reagents.
Baidu Encyclopedia - In Vitro Diagnostic Reagents