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China NMPA legacy archive 苏械注准20242401204

血管紧张素Ⅰ测定试剂盒(化学发光免疫分析法)

Getein Biotech, Inc.Class IINMPAApproved May 31, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
10人份、2×10人份、3×10人份、4×10人份、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 information
Registration number
苏械注准20242401204
Approval date
May 31, 2024
Expiry date
May 30, 2029
Registrant
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 facility
Production address
南京市六合区沿江工业开发区博富路9号,南京市江北新区科丰路6号
Intended use
English

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。

Structure and composition
English

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)。

Storage conditions and expiration
English

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.

中文

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。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for 血管紧张素Ⅰ测定试剂盒(化学发光免疫分析法), registration 苏械注准20242401204. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.