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What are the classification of in vitro diagnostic reagents ?

2020-07-24 来源:转载自第三方

In-vitro diagnostic reagents are a subdivision of the in-vitro diagnostic industry, which is a part of medical devices and plays an important role in disease prevention, diagnosis, treatment monitoring, and health status evaluation. And they are divided into different types according to different standards.

The most common classification principle is in accordance with the "in vitro diagnostic reagents registration management measures", according to the product risk degree from high to low, mainly divided into the third category, the second category, the first category, and the implementation of classified registration management [1].

According to management principles, it is also an important classification method for in vitro diagnostic reagents. First, according to the principles of in vitro diagnostic reagents for drug acceptance and review, in vitro diagnostic reagents can be divided into seven categories, including blood type, tissue matching type reagents; microbial antigens, Antibody and nucleic acid detection reagents; tumor marker reagents; immunohistochemistry and human tissue cell reagents; human gene detection reagents; biochips; allergy diagnosis reagents. Secondly, in vitro diagnostic reagents are divided into 9 types according the accepted and reviewed by medical devices  , including clinical hematology and body fluids test reagents, clinical chemistry test reagents, clinical immunological test reagents and microbiological test reagents.

Classification of in vitro diagnostic reagents according to detection principles is the current mainstream classification method. According to this classification principle, in vitro diagnostic reagents can be divided into biochemical diagnostic reagents, immunological diagnostic reagents, molecular diagnostic reagents, microbial diagnostic reagents, urine diagnostic reagents, blood coagulation diagnostic reagents, hematology and flow cytometry diagnostic reagents.

Biochemical, immunological and molecular diagnostic reagents are the three main types of diagnostic reagents in my country. At present, nucleic acid diagnostics in molecular diagnostics occupy the main market.