血管紧张素Ⅰ测定试剂盒（化学发光免疫分析法） - NMPA Registration 苏械注准20242401204
Access comprehensive regulatory information for 血管紧张素Ⅰ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20242401204 and owned by Getein Biotech, Inc.. The device was approved on May 31, 2024.
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用于体外定量检测人体血浆中血管紧张素I（Angiotensin I，Ang I）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，（2.56±0.6）ng/mL，大肠杆菌表达血管紧张素I重组蛋白抗原， 20mM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，（12.78±4.2）ng/mL，大肠杆菌表达血管紧张素I重组蛋白抗原， 20mM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I单克隆小鼠抗体（1±0.1 μg/mL），含150mmol/L氯化钠，牛血清白蛋白，pH=6.8±0.8；含0.1%普乐净PC-300防腐剂。L4：生物素标记的血管紧张素I抗原类似物（50±5 ng/mL），含150mmol/L氯化钠，牛血清白蛋白，pH=6.8±0.8；含0.1%普乐净PC-300防腐剂。辅助试剂1：0.034 mol/L 8-羟基喹啉硫酸盐溶液（酶抑制剂）。辅助试剂2：0.032 mol/L 二巯基丙醇溶液。pH调节剂：0.5 mol/L 磷酸盐缓冲液（调节剂）。
Unopened reagents are stored at 2~8 °C, and the validity period is 12 months; The bottle opening reagent is stored at 2~8 °C, and the validity period is 30 days; Immediately after opening, store in the reagent warehouse at 8~14 °C, the validity period is 30 days.
未开瓶试剂2~8℃保存，有效期为12个月；开瓶试剂2~8℃保存，有效期为30天；开瓶后立即于试剂仓8~14℃保存，有效期为30天。