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2024.04.11
Definition and Classification of In Vitro Diagnosis
In-vitro diagnostics (IVD) refers to diagnostic methods that obtain clinical diagnostic information by testing human samples (blood, body fluids, cells, tissues, etc.) outside the human body. Internationally, it is known as IVD (in-vitro diagnostics).
What are in-vitro diagnostic reagents?
In vitro diagnostic reagents are in vitro diagnostic reagents managed in accordance with medical device regulations. They are classified into Class III, Class II, and Class I products based on the level of product risk.
2018.05.07
The IVD Industry—New Situations and Problems in the Era of "Grand Testing"
The strengthening of national health awareness, the continuous expansion of the medical market, and the rapid development of laboratory medicine have brought unprecedented development opportunities to the in-vitro diagnostic (IVD) industry. Through the efforts of a group of IVD entrepreneurs, the level of IVD equipment in China has made a qualitative leap, and domestic IVD equipment and reagents have emerged in large numbers, with some products already entering medical laboratories in developed European and American countries. In the face of the rapid development of the industry, the organic combination of research and development and production, laboratory medicine, and clinical needs is becoming increasingly critical. In order to further explore the hot issues in the IVD industry, reflect new progress, exchange new ideas, and serve research and development and production,