In vitro diagnostic reagents are reagents, kits, calibrators, and quality control reagents that can be used alone or in combination with instruments, apparatus, equipment, or systems for in vitro testing of human samples (various bodily fluids, cells, and tissue samples, etc.) in the process of disease prevention, diagnosis, therapeutic monitoring, prognostic observation, evaluation of the state of health, and prediction of hereditary diseases. The term "reagents" refers to reagents, kits, calibrators, quality control products, and so on.