The in vitro diagnostic reagents referred to in the "In Vitro Diagnostic Reagent Registration Management Measures (Trial)" refers to the in vitro diagnostic reagents that are managed according to the medical devices, 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, observation of the prognosis, 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 the third category, the second category and the first category of products in 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 targets.
Expanded Information:
The development of in vitro diagnostic reagent industry is extremely similar to that of the home appliance industry in the early 90s of the last century: on the one hand, the market is very large. On the other hand, the monopoly advantage of imported reagents and diagnostic instruments is being broken and constrained by national products." This is a summary of the current state of development of in vitro diagnostic reagents 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