Nucleic acid extraction reagents are in vitro diagnostic kits.
In vitro diagnostic reagents and devices are collectively called in vitro diagnostic medical devices abroad. Part of the medical device.
In my country, in vitro diagnostic reagents refer to reagents that can be used alone or in combination with instruments, appliances, equipment or systems for disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and genetic testing. In the process of disease prediction, reagents, kits, calibrators (materials), quality control materials (materials), etc. are used for in vitro detection of human samples (various body fluids, cells, tissue samples, etc.).