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Complement C1q assay kit (immunoturbidimetry) - NMPA Registration 京械注准20242400126

Access comprehensive regulatory information for Complement C1q assay kit (immunoturbidimetry) 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20242400126 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on March 22, 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20242400126
Complement C1q assay kit (immunoturbidimetry)
补体C1q测定试剂盒（免疫比浊法）
NMPA Registration Number: 京械注准20242400126
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Intended Use
English

It is used for in vitro quantitative determination of complement C1q content in human serum.

中文

用于体外定量测定人血清中的补体C1q的含量。

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1:60mL; 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1:90mL; 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1:15mL; 1,试剂2:5mL; 1;试剂1:3L; 1,试剂2:1L; 1;试剂1:15L; 1,试剂2:5L; 1;试剂1:45mL; 1,试剂2:15mL; 1;试剂1:45ml; 2,试剂2:15ml; 2;校准品(5水平,选配):0.5mL; 5;1mL; 5;质控品(2水平,选配):0.5mL; 2;1mL; 2.
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1：60mL;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1：90mL;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1：15mL;1，试剂2：5mL;1；试剂1：3L;1，试剂2：1L;1；试剂1:15L;1，试剂2:5L;1；试剂1：45mL;1，试剂2:15mL;1；试剂1：45ml;2，试剂2:15ml;2；校准品（5水平，选配）：0.5mL;5；1mL;5；质控品（2水平，选配）：0.5mL;2；1mL;2。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400126
Approval Date
March 22, 2024
Expiry Date
March 21, 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

Note: The calibrators and controls are batch-specific, and the specific concentrations are shown in the target value sheet.

中文

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

The kit is stored at 2°C~8°C and is valid for 12 months.

中文

试剂盒2℃～8℃保存，有效期12个月。