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九强生物:取得两项医疗器械注册证书
Core Viewpoint - Jiukang Bio (300406) has recently received a medical device registration certificate from the Beijing Drug Administration for two new products, indicating a significant advancement in its product offerings [1] Product Registration - The first product is the "Heparin Binding Protein Assay Kit (Magnetic Microparticle Chemiluminescent Immunoassay)," which is designed for the in vitro quantitative measurement of heparin binding protein (HBP) levels in human plasma [1] - The second product is the "Fully Automatic Biochemical Analyzer (Models: Gc2000, Gc2400)," which is intended to be used in conjunction with compatible reagents for qualitative and quantitative analysis of substances in human samples [1]
九强生物取得两项医疗器械注册证
Zhi Tong Cai Jing· 2025-11-03 07:59
Core Viewpoint - The company, Jiukang Biological, has received medical device registration certificates from the Beijing Drug Administration for two products, indicating a significant step in its product development and regulatory approval process [1] Group 1 - The company has obtained registration for the Heparin Binding Protein Assay Kit, which utilizes magnetic microparticle chemiluminescent immunoassay technology [1] - The company has also received approval for the fully automated biochemical analyzer, models Gc2000 and Gc2400, expanding its product offerings in the medical device sector [1]
九强生物(300406.SZ)取得两项医疗器械注册证
智通财经网· 2025-11-03 07:56
Core Viewpoint - The company, Jiukang Biological, has received medical device registration certificates from the Beijing Drug Administration for two products, indicating a significant regulatory milestone for the company [1] Group 1: Product Information - The registered products include the Heparin Binding Protein Assay Kit (using magnetic microparticle chemiluminescent immunoassay) and the fully automatic biochemical analyzer (models Gc2000 and Gc2400) [1]