全自动化学发光免疫分析仪(AutoLumo S900

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安图生物:全自动化学发光免疫分析仪获注册证
news flash· 2025-05-30 08:17
Core Viewpoint - Antu Biology (603658) has received medical device registration certificates from the National Medical Products Administration and the Henan Provincial Drug Administration for several products, indicating a significant advancement in its product offerings and regulatory compliance [1] Group 1: Product Registration - The company and its wholly-owned subsidiary, Antu Laboratory Instruments (Zhengzhou) Co., Ltd., have obtained registration for the cytomegalovirus IgM antibody test kit (magnetic microparticle chemiluminescence method) [1] - The company has also received registration for the carbamazepine test kit (liquid chromatography-tandem mass spectrometry method) [1] - Additionally, the company has registered several models of fully automated chemiluminescence immunoassay analyzers (AutoLumo S900, AutoLumo S920, AutoLumo S960, AutoLumo S980) [1] Group 2: Application of Products - The fully automated chemiluminescence immunoassay analyzers are designed for qualitative or quantitative detection of analytes from various human-derived samples, including serum, plasma, whole blood, urine, saliva, sputum, cerebrospinal fluid, bronchoalveolar lavage fluid, swab elution fluid, swab processing fluid, and fecal samples [1] - The analyzers can detect tumor-related antigens, liver diseases, hormones, infectious diseases, immune functions, autoantibodies, proteins and peptides, myocardial diseases, vitamins, amino acids, blood drug concentrations, allergens, kidney diseases, coagulation tests, and other enzyme-related and testing projects [1]