According to the Zhitong Finance APP, Maccura (300463.SZ) announced that it recently received the "Medical Device Registration Certificate" (in vitro diagnostic reagents) issued by the National Medical Products Administration. The product names are: Irregular Antibody Detection Red Blood Cell Reagent Kit (Column Agglutination Method) and Mycoplasma Pneumoniae IgM Antibody Detection Reagent Kit (Direct Chemiluminescence Method).

The Irregular Antibody Detection Red Blood Cell Reagent Kit (Column Agglutination Method) is mainly used to detect the presence of irregular antibodies in the tested plasma and is a new reagent product from the company's blood type platform. The Mycoplasma Pneumoniae IgM Antibody Detection Reagent Kit (Direct Chemiluminescence Method) is primarily used for the auxiliary diagnosis of Mycoplasma pneumoniae infection and is a new reagent product from the direct chemiluminescence platform, compatible with the company's fully automated chemiluminescence immunoassay analyzers i6000, i3000 series, i1000 series, and i800 series. As of now, the company has obtained a total of 133 reagent product registration certificates under the direct chemiluminescence platform (covering tests for thyroid function, infectious diseases, myocardial markers, tumor markers, anemia, inflammation, autoimmune diseases, reproductive hormones, bone metabolism, and other disease detections). The acquisition of registration certificates for new products further enriches the company's product portfolio, helps enhance the company's overall market competitiveness, and will have a positive impact on market expansion and the company's future operations