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Superoxide dismutase determination reagent kit (SOD substrate method) - NMPA Registration 京械注准20242400028

Access comprehensive regulatory information for Superoxide dismutase determination reagent kit (SOD substrate method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400028 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on January 16, 2024.

This page provides complete registration details including registrant information, province location (Beijing), 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.

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Class II
京械注准20242400028
Superoxide dismutase determination reagent kit (SOD substrate method)
超氧化物歧化酶测定试剂盒(SOD底物法)
NMPA Registration Number: 京械注准20242400028
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Intended Use
English

It is used for in vitro quantitative determination of the activity of superoxide dismutase in human serum or plasma.

中文

用于体外定量测定人血清或血浆中的超氧化物歧化酶的活性。

Device Classification
Device Class
Class II
Model Specifications
试剂1:12mL; 1,试剂2:4mL; 1;试剂1:12mL; 3,试剂2:4mL; 3; 试剂1:12mL; 4,试剂2:4mL; 4;试剂1:12mL; 5,试剂2:4mL; 5; 试剂1:12mL; 6,试剂2:4mL; 6;试剂1:12mL; 7,试剂2:4mL; 7; 试剂1:12mL; 8,试剂2:4mL; 8;试剂1:12mL; 9,试剂2:4mL; 9; 试剂1:12mL; 10,试剂2:4mL; 10;试剂1:15mL; 1,试剂2:5mL; 1; 试剂1:60mL; 1,试剂2:20mL; 1;试剂1:60mL; 2,试剂2:20mL; 2; 试剂1:60mL; 3,试剂2:20mL; 3;试剂1:60mL; 3,试剂2:60mL; 1; 试剂1:60mL; 4,试剂2:20mL; 4;试剂1:60mL; 2,试剂2:40mL; 1; 试剂1:60mL; 4,试剂2:40mL; 2;试剂1:60mL; 5,试剂2:50mL; 2; 试剂1:60mL; 5,试剂2:20mL; 5;试剂1:60mL; 6,试剂2:60mL; 2; 试剂1:60mL; 6,试剂2:20mL; 6;试剂1:45mL; 1,试剂2:15mL; 1; 试剂1:90mL; 1,试剂2:30mL; 1;试剂1:90mL; 2,试剂2:60mL; 1; 试剂1:90mL; 3,试剂2:90mL; 1;试剂1:90mL; 4,试剂2:60mL; 2; 试剂1:90mL; 6,试剂2:90mL; 2;试剂1:45ml; 2,试剂2:15ml; 2; 试剂1:3L; 1,试剂2:1L; 1;试剂1:15L; 1,试剂2:5L; 1; 校准品:1mL; 1(冻干粉,选配); 质控品:1mL; 2(2水平,冻干粉,选配).
试剂1:12mL;1,试剂2:4mL;1;试剂1:12mL;3,试剂2:4mL;3; 试剂1:12mL;4,试剂2:4mL;4;试剂1:12mL;5,试剂2:4mL;5; 试剂1:12mL;6,试剂2:4mL;6;试剂1:12mL;7,试剂2:4mL;7; 试剂1:12mL;8,试剂2:4mL;8;试剂1:12mL;9,试剂2:4mL;9; 试剂1:12mL;10,试剂2:4mL;10;试剂1:15mL;1,试剂2:5mL;1; 试剂1:60mL;1,试剂2:20mL;1;试剂1:60mL;2,试剂2:20mL;2; 试剂1:60mL;3,试剂2:20mL;3;试剂1:60mL;3,试剂2:60mL;1; 试剂1:60mL;4,试剂2:20mL;4;试剂1:60mL;2,试剂2:40mL;1; 试剂1:60mL;4,试剂2:40mL;2;试剂1:60mL;5,试剂2:50mL;2; 试剂1:60mL;5,试剂2:20mL;5;试剂1:60mL;6,试剂2:60mL;2; 试剂1:60mL;6,试剂2:20mL;6;试剂1:45mL;1,试剂2:15mL;1; 试剂1:90mL;1,试剂2:30mL;1;试剂1:90mL;2,试剂2:60mL;1; 试剂1:90mL;3,试剂2:90mL;1;试剂1:90mL;4,试剂2:60mL;2; 试剂1:90mL;6,试剂2:90mL;2;试剂1:45ml;2,试剂2:15ml;2; 试剂1:3L;1,试剂2:1L;1;试剂1:15L;1,试剂2:5L;1; 校准品:1mL;1(冻干粉,选配); 质控品:1mL;2(2水平,冻干粉,选配)。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400028
Approval Date
January 16, 2024
Expiry Date
January 15, 2029
Registrant
Name
Beijing Enjihe Biological Engineering Co., Ltd.
乐普(北京)诊断技术股份有限公司
Province/Region
Beijing
北京
Address
205, Building 1, No. 6 Lixiang Road, Nanshao Town Science and Technology Park, Changping District, Beijing
北京市昌平区南邵镇科技园区利祥路6号1幢205
Production Facility
Production Address
北京市平谷区马坊镇盘龙西路21号院3号楼二层
Structure and Composition
English

The main components of reagent 1 are: Phosphate buffer 100mmol/L,pH6.8 The main components of reagent 2: Pyrogallol 1mmol/L The main components of the calibrator are: Phosphate buffer 50mmol/L,pH6.8 Superoxide dismutase 100.0~200.0U/mL Key components of the control: Phosphate buffer 50mmol/L,pH6.8 Superoxide dismutase Level 1: 70.0~150.0U/mL Level 2: 150.0~250.0U/mL Note: The calibrators and controls are batch-specific, and the specific concentrations are shown in the target value sheet.

中文

试剂1主要组成成分: 磷酸盐缓冲液 100mmol/L,pH6.8 试剂2主要组成成分: 邻苯三酚 1mmol/L 校准品主要组成成分: 磷酸盐缓冲液 50mmol/L,pH6.8 超氧化物歧化酶 100.0~200.0U/mL 质控品主要组成成分: 磷酸盐缓冲液 50mmol/L,pH6.8 超氧化物歧化酶 水平1:70.0~150.0U/mL 水平2:150.0~250.0U/mL 注:校准品及质控品具有批特异性,具体浓度见靶值单。

Storage Conditions and Expiration
English

2℃~8℃保存,

中文

2℃~8℃保存,

Additional Information
Appendix
产品技术要求、说明书