In Vitro Diagnostic Industry in China - Blood Typing Instruments and Reagents V

3. Blood Typing Instruments and Its Technology Development Direction and Status of Market Development

3.1. Main Brands and Manufacturers of Domestic Automatic Blood Grouping Analyzers

Microplate-based automatic blood grouping analyzer Metis of Aikang MedTech Co., Ltd. (henceforth referred to as Aikang) received approval for marketing in 2015; and its MGT-based automatic blood grouping analyzer Aigel received approval for marketing in 2016. Both products can conduct the test of forward and reverse human blood ABO, Rh (D) blood typing, irregular antibody screening, and cross-matching of blood. Aikang became the only domestic enterprise in possession of microplate-based and MGT-based automatic blood grouping analyzers.

Subsequently, MG12 automatic blood grouping analyzer of Zhongshan Bio-Tech Co., Ltd. (henceforth referred to as Zhongshan Bio-Tech), SA-120 automatic blood grouping analyzer of Suzhou Hybiome Biomedical Engineering Co., Ltd. (henceforth referred to as Suzhou Hybiome), Aretha automatic blood grouping analyzer of Shinva Medical Instrument Co.,Ltd.(henceforth referred to as Shinva), and other excellent domestic enterprises’ MGT-based automatic blood grouping analyzer received approval for marketing successively. Manual tube method-based BG-Optics-II automatic blood grouping analyzer of Baso Zhuhai Bio-Tech Co., Ltd. (henceforth referred to as Baso) received approval for marketing in 2020, which further enriched categories of domestic blood typing instruments and brought new experiences to users. See details of partial domestic automatic blood grouping analyzer brands and manufacturers in Table 1.

At present, application method of domestic brands of automatic blood grouping analyzer has covered MGT, microplate and tube method, and their basic functions involve automatic barcode scanning, sampling, reagent injection, incubation, centrifugation, oscillation, and result interpretation. They can conduct the test of forward and reverse human blood ABO blood group, Rh (D) blood typing, irregular antibody screening and cross-matching of blood, and meet requirements of clinical blood typing and analysis. Domestic brands of automatic blood grouping analyzer have received excellent feedbacks from users in terms of functional practicability, operational simplicity, and maintenance convenience.

Table 1 Domestic automatic blood grouping analyzer brands and manufacturers

Note: See National Medical Products Administration’s Medical Device Database for reference

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