In-vitro diagnostic reagents are a subdivision of the in-vitro diagnostic industry. They are part of medical devices and play an important role in disease prevention, diagnosis, treatment monitoring, and health status evaluation. There are many classification methods for in vitro diagnostic reagents, and there are different types according to different classification principles. The following Desheng introduces you the classification methods and classification principles of in vitro diagnostic reagents.
The most common classification principle is according to the "In Vitro Diagnostic Reagent Registration Management Measures", according to the order of the degree of product risk from high to low. Mainly divided into the third category, the second category, the first category, and implement classified registration management.
According to the management principle, it is also an important classification method for in vitro diagnostic reagents. First, according to the principle 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 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, according to the in vitro diagnostic reagents accepted and reviewed by medical devices, it includes a total of nine types of clinical hematology and humoral test reagents, clinical chemistry test reagents, clinical immunological test reagents and microbiological test reagents.
The management classification method needs to be specially pointed out that the in vitro diagnostic reagents managed in accordance with the medical device production supervision and management methods, excluding the in vitro diagnostic reagent products that are legally used for blood source screening and radionuclide labeling by the state.
Another is to classify in vitro diagnostic reagents according to the detection principle, which 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.
Since its establishment in 2005, Desheng has been focusing on the R&D and production of in vitro diagnostic reagent raw materials. The raw materials of diagnostic reagents include: biological buffers, chromogen substrates, and current chromogen substrates (new Trinder's reagents) include TOOS, TOPS, ADOS, ADPS, ALPS, DAOS, HDAOS, MADB, MAOS, TODB, etc. Buffers include Tris, Bicine, Caps, Mops, Taps, EPPS, etc.
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