In Vitro diagnostic reagent (IVD) is a product and service that obtains biological information about the human body by testing human samples (blood, body fluids, tissues, etc.) outside the human body. It is the main source of information for human disease prevention, diagnosis, observation of treatment effects and health protection decisions, and plays a vital role in maintaining the health of all people.
In vitro diagnostic reagents are products such as reagents, kits, calibrators and quality control products used for in vitro testing of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation.
They can be used individually or in combination with instruments, apparatus, equipment or systems.
In vitro diagnostic reagents can be divided into several categories according to clinical use and testing principle methods, such as biochemical diagnostic reagents, immune diagnostic reagents, molecular diagnostic reagents, microbial diagnostic reagents and hematological diagnostic reagents.