Core Viewpoint - The company, Maike Bio (300463.SZ), has received a medical device registration certificate from the Sichuan Provincial Drug Administration for its new product, the Glial Fibrillary Acidic Protein Assay Kit, which is intended for auxiliary diagnosis of central nervous system diseases [1] Group 1: Product Registration and Purpose - The Glial Fibrillary Acidic Protein Assay Kit is a new reagent product under the company's direct chemiluminescence platform, used in conjunction with the company's fully automated chemiluminescence immunoassay analyzers (i6000, i3000, i1000, and i800 series) [1] - The company has obtained a total of 138 product registration certificates for reagent products under the direct chemiluminescence platform, covering various disease detections including thyroid function, infectious diseases, myocardial, tumor markers, anemia, inflammation, autoimmune diseases, reproductive hormones, and bone metabolism [1] - The blood cell analyzer quality control products and calibration products are newly added to the company's blood cell platform, ensuring the accuracy of clinical blood cell analysis results [1] Group 2: Registration Details - The blood cell analyzer quality control product has a registration number of 20252400168, valid from September 24, 2025, to September 23, 2030, and is used for quality control of blood cell analysis projects [2] - The Glial Fibrillary Acidic Protein Assay Kit has a registration number of 20252400179, valid from October 17, 2025, to October 16, 2030, for the quantitative measurement of glial fibrillary acidic protein concentration in human serum or plasma [2] - The blood cell analyzer calibration product has a registration number of 20252400180, valid from October 17, 2025, to October 16, 2030, for calibrating parameters such as WBC, RBC, HGB, HCT, and PLT in blood cell analysis [2]

Core Viewpoint - The company, Maike Bio (300463.SZ), has received a medical device registration certificate from the Sichuan Provincial Drug Administration for its new product, the Glial Fibrillary Acidic Protein Assay Kit, which is intended for auxiliary diagnosis of central nervous system diseases [1] Group 1: Product Registration and Purpose - The Glial Fibrillary Acidic Protein Assay Kit is a new reagent product under the company's direct chemiluminescence platform, primarily used for the auxiliary diagnosis of central nervous system diseases [1] - The company has obtained a total of 138 registration certificates for reagent products under the direct chemiluminescence platform, covering various disease detections including thyroid function, infectious diseases, cardiac markers, tumor markers, anemia, inflammation, autoimmune diseases, reproductive hormones, and bone metabolism [1] - The blood cell analyzer quality control product is a new quality control product for the blood cell platform, used to monitor the operational status of blood cell analyzers to ensure the accuracy of clinical blood cell analysis results [1] Group 2: Calibration Products - The blood cell analyzer calibration product is also a new addition to the blood cell platform, used for calibrating parameters such as WBC, RBC, HGB, HCT, and PLT in blood cell analyzers, establishing metrological traceability for measurement results [1] - The registration certificates for the blood cell analyzer quality control product and calibration product are valid until September 24, 2030, and October 16, 2030, respectively [2]