美康生物（300439）(300439.SZ)公告，公司的控股子公司江西美康盛德生物科技有限公司(简称"江西美 康")取得了由江西省药品监督管理局颁发的《医疗器械注册证(体外诊断试剂)》，产品包括：组织型纤 溶酶原激活剂-抑制剂1复合物检测试剂盒(化学发光免疫分析法)、凝血酶-抗凝血酶复合物检测试剂盒 (化学发光免疫分析法)、血栓调节蛋白检测试剂盒(化学发光免疫分析法)、纤溶酶-α2纤溶酶抑制剂复合 物检测试剂盒(化学发光免疫分析法)。 ...

美康生物9月17日公告，公司的控股子公司江西美康盛德生物科技有限公司（简称"江西美康"）取得了由江西省药品监督管理局 颁发的《中华人民共和国医疗器械注册证（体外诊断试剂）》，具体情况如下： | 序号 | 注册人名称 | 产品名称 | 注册证编号 | 注册证有效期间 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 1 | 江西美康 | 组织型纤溶酶原激活剂- 抑制剂 1 复合物检测试剂 | 赣 械 注 准 20252400203 | 2025年9月15日至 2030年9月14日 | 用于体外定量测定人血浆中 | | | | | | | 组织型纤溶酶原激活剂-抑制 | | | | | | | 剂 1 复合物(t-PAIC)的浓度。 | | | | | | | 临床上用于心血管疾病和弥 | | | | 盒(化学发光免疫分析法) | | | 散性血管内凝血血栓的辅助 | | | | | | | 诊断。 | | 2 | 江西美康 | 凝血酶-抗凝血酶复合物 检测试剂盒(化学发光免 | 赣 械 注 准 | 2025年9月15日至 | 用于体外定量测定人血浆中 凝血酶-抗凝 ...

Core Viewpoint - Meikang Biotech (300439.SZ) has obtained the Medical Device Registration Certificate for in vitro diagnostic reagents from the Jiangxi Provincial Drug Administration, enhancing its product line in the field of chemiluminescence diagnostics and positively impacting its core competitiveness and market expansion capabilities [1]. Group 1: Product Registration Details - The registered product is a complex of tissue-type plasminogen activator-inhibitor 1 detection reagent, valid from September 15, 2025, to September 14, 2030, used for quantitative measurement of t-PAIC concentration in human plasma, aiding in the diagnosis of cardiovascular diseases and disseminated intravascular coagulation [2]. - Another registered product is the thrombin-antithrombin complex detection reagent, also valid from September 15, 2025, to September 14, 2030, used for assessing coagulation activation status and assisting in the diagnosis of thrombotic diseases [2]. - The company has also registered a thrombomodulin detection reagent, valid for the same period, which is used for quantitative measurement of TM concentration in human plasma, assisting in the diagnosis of endothelial cell injury [2]. - Additionally, a detection reagent for plasmin-α2-plasmin inhibitor complex has been registered, with the same validity period, aimed at assisting in the diagnosis of thrombotic diseases [2].