新产业:全自动化学发光免疫分析仪获注册证
Core Viewpoint - The company has received a medical device registration certificate for its fully automated chemiluminescence immunoassay analyzer, indicating a significant advancement in its product offerings in the medical device sector [1] Group 1: Product Details - The product is named MAGLUMI X10 and is classified as a Class II medical device [1] - The registration certificate number is 粤械注准20252220811, with a validity period from June 10, 2025, to June 9, 2030 [1] - The analyzer utilizes a direct chemiluminescence method based on luminol derivatives, designed for qualitative or quantitative detection of analytes in human-derived samples such as serum, plasma, urine, and whole blood [1]