What are in vitro diagnostic reagents

In vitro diagnostic reagents refer to reagents, kits, calibrators, quality control products and other products that can be used alone or in combination with instruments, apparatus, equipment or systems for in vitro testing of human samples in the process of disease prevention, diagnosis, treatment monitoring, prognostic observation, evaluation of the state of health, as well as prediction of hereditary diseases. According to the degree of product risk, in vitro diagnostic reagents are categorized into Category III, Category II, and Category I products in that order. Specifically, Category III products include reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens, reagents related to blood grouping and tissue mating, reagents related to human gene detection, etc. Category II products mainly include reagents used for protein detection, reagents used for glucose detection and reagents used for hormone detection, etc. Category I products are products for microbial culture media and sample processing, such as hemolysates, diluents, etc. agent, diluent, etc.