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A: Classification of in vitro diagnostic reagents:
1. In vitro biodiagnostic reagents managed as drugs include:
1. Blood type and tissue type reagents;
2. Microbial antigen, antibody and nucleic acid detection reagents;
3. Tumor marker reagents;
4. Immunohistochemistry and human tissue cell reagents;
5. Human genetic testing reagents;
6. Biochips;
7. Allergy diagnostic reagents.
2. In vitro reagents managed as medical devices include:
1. Clinical basic test reagents;
2. Clinical chemistry reagents;
3. Blood gas and electrolyte determination reagents;
4. Vitamin determination reagents;
5. Cell histochemical stains;
6. Autoimmune diagnostic reagents;
7. Microbiological test reagents.
B: According to medical test items, clinical diagnostic reagents can be roughly divided into clinical chemical test reagents, immunology and
Serological testing reagents, hematological and cytogenetic testing reagents, microbiological testing reagents, body fluid excretion
Detection reagents, genetic diagnosis reagents, etc. Among them, the market share of clinical chemistry
The largest, close to 34%; followed by the immunology market, accounting for about 29%. Novel immunodiagnostic reagents and genetic diagnostic tests
The reagent was developed in the late 1980s, and it is the most common diagnostic reagent for all current diagnostic reagents, regardless of technology or market.
The fastest growing product.
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