血管紧张素II测定试剂盒（化学发光免疫分析法） - NMPA Registration 苏械注准20242401142
Access comprehensive regulatory information for 血管紧张素II测定试剂盒（化学发光免疫分析法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20242401142 and owned by Getein Biotech, Inc.. The device was approved on May 23, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
用于体外定量检测人体血浆中血管紧张素II（Angiotensin II）的含量。
L1：链霉亲和素包被的磁性微粒，2.50mg/mL；含0.1%普乐净PC-300防腐剂。L：校准品L，（50-120 pg/mL） 大肠杆菌表达，血管紧张素II重组蛋白抗原， 50mM磷酸盐缓冲液，PH=7.4±0.2，含0.1% 普乐净PC-300防腐剂。H：校准品H，（300-500 pg/mL）大肠杆菌表达，血管紧张素II重组蛋白抗原， 50mM磷酸盐缓冲液，PH=7.4±0.2，含0.1% 普乐净PC-300防腐剂。L3：吖啶酯标记的血管紧张素II单克隆小鼠抗体(0.125-0.25 μg/mL)，150mmol/L氯化钠，牛血清白蛋白，pH=6.0±0.2；0.1% 普乐净PC-300防腐剂。L4：生物素化的血管紧张素II抗原类似物(0.375-0.75 μg/mL)，化学合成，150mmol/L氯化钠，牛血清白蛋白，pH=6.0±0.2；0.1% 普乐净PC-300防腐剂。辅助试剂1：0.034M 8-羟基喹啉硫酸盐溶液（酶抑制剂），pH=1.6±0.1。辅助试剂2：0.032M 二巯基丙醇溶液，pH=4.0±0.2。
未开瓶试剂及校准品2~8℃保存，有效期为12个月；开瓶试剂及校准品2~8℃保存，有效期为30天；开瓶后试剂及校准品立即于试剂仓8~14℃保存，有效期为30天。