In vitro diagnostic reagents are in vitro diagnostic reagents managed as medical devices, including reagents, kits, calibrators, quality control products and other 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. In vitro diagnostic reagents can be used in combination with instruments, apparatus, equipment or systems.

These are the reagents for testing for various parameters in blood or urine sample using chemical or enzymatic methods.