In vitro diagnostic reagents refers to in vitro diagnostic reagents managed as medical devices, including reagents, kits, calibrators, calibrators, etc., which can be used alone or in combination with instruments, apparatuses, equipment or systems for in vitro testing of human body samples (various bodily fluids, cells, tissue samples, etc.) in the process of prevention, diagnosis of diseases, monitoring of treatments, prognosis, evaluation of the state of health, as well as the prediction of hereditary diseases. （Reagents, kits, calibrators, and quality control products.
In vitro diagnostic reagents belong to the category of medical devices according to the Regulations for the Supervision and Administration of Medical Devices.