China NMPA legacy archive 苏械注准20242401142血管紧张素II测定试剂盒（化学发光免疫分析法）
- Device class
- Class II
- Model specifications
- 10 servings/box, 2×10 servings/box, 3×10 servings/box, 4×10 servings/box, 25 servings/box, 2×25 servings/box, 3×25 servings/box, 4×25 servings/box, 50 servings/box, 2×50 servings/box, 3×50 servings/box, 4×50 servings/box, 75 servings/box, 2×75 servings/box, 3×75 servings/box, 100 servings/box, 2×100 servings/box, 150 persons/box, 200 servings/box.
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242401142
- Approval date
- May 23, 2024
- Expiry date
- May 22, 2029
- Province/Region
- Jiangsu
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
- Production address
- 南京市江北新区科丰路6号,南京市六合区沿江工业开发区博富路9号
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。
- Appendix
- 产品技术要求、说明书
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