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.10人份/盒、2×10人份/盒、3×10人份/盒、4×10人份/盒、25人份/盒、2×25人份/盒、3×25人份/盒、4×25人份/盒、50人份/盒、2×50人份/盒、3×50人份/盒、4×50人份/盒、75人份/盒、2×75人份/盒、3×75人份/盒、100人份/盒、2×100人份/盒、150人份/盒、200人份/盒。
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20242401142
- Approval date
- May 23, 2024
- Expiry date
- May 22, 2029
- Name
- Getein Biotech, Inc.基蛋生物科技股份有限公司
- Province/Region
- Jiangsu江苏
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing南京市六合区沿江工业开发区博富路9号
- 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
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.