In vitro diagnostic reagents and instruments are uniformly called in vitro diagnostic medical devices in foreign countries. They are part of medical devices.
In our country, 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.) for the in vitro testing of the reagents, reagent kits, calibrators (things), quality control products (things) and so on. The company's products are used for in vitro testing of human samples (various body fluids, cells and tissues).