In vitro diagnostic reagents are part of medical devices. In vitro diagnostic reagents are mainly kits, calibrators, quality control products, reagents, etc. that can be used alone or in combination with instruments, equipment, apparatus or systems, etc., for in vitro testing of human samples such as cells, body fluids and tissue samples in the process of prevention, diagnosis of diseases, monitoring of treatments, evaluation of the state of health, observation of prognosis and prediction of hereditary diseases. Clinics also categorize products into Class III, Class II, and Class I products based on the degree of risk. Generally, Class III products are mainly related to pathogenic pathogen antigens, human genetic testing, hereditary diseases, tumor marker testing, etc., while Class II products include the removal of Class I products and Class III products. Class I products include microbial culture media and products for sample processing. It is recommended that people usually recognize in vitro diagnostic reagents normally, and actively cooperate with doctors for relevant examinations when necessary.