In vitro diagnosis (IVD, InVitroDiagnosis) refers to products and services that obtain clinical diagnostic information by testing human samples (blood, body fluids, interstitial fluids, etc.) outside the human body, and then determine the disease or body function.
In vitro diagnostic products include: diagnostic instruments, diagnostic reagents and related calibration quality control and other peripheral consumables. In vitro diagnostic products belong to a type of medical device. According to the possibility of damage to the human body and the impact on the medical effect during use, medical devices can be divided into contact or entering human body equipment and non-contact human body alkali according to the state of use; At the same time, according to different forms of use, medical devices are divided into active medical devices and passive medical devices. In vitro diagnostic products do not directly affect the human body, and according to the division in the (Medical Device Classification Rules), in vitro diagnostic products are classified as "non-contact human devices" category.
The technology of genetic testing and in vitro diagnosis is constantly innovating, and the demand for technical exchange and multi-scenario cooperation within the industry is also increasing.
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