In vitro diagnostic reagents and instruments are uniformly called in vitro diagnostic medical devices in foreign countries. It belongs to the part of medical devices. In China, in vitro diagnostic reagents refers to: can be used alone or in combination with instruments, apparatus, equipment or systems, in the process of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and prediction of hereditary diseases, for human samples (a variety of bodily fluids, cells, tissues samples, etc.) in vitro detection of the reagents, reagent kits, calibrators (things), quality control products (things) and so on.