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Complement C1q Assay Kit (Immunoturbidimetry) - NMPA Registration 吉械注准20242400607

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 吉械注准20242400607 and owned by Dirui Industrial Co., Ltd.. The device was approved on September 12, 2024.

This page provides complete registration details including registrant information, province location (Jilin), 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
吉械注准20242400607
Complement C1q Assay Kit (Immunoturbidimetry)
补体C1q测定试剂盒(免疫比浊法)
NMPA Registration Number: 吉械注准20242400607
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Intended Use
English

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

中文

用于体外定量测定人血清中补体C1q的浓度。

Device Classification
Device Class
Class II
Model Specifications
See the product technical requirements for details
详见产品技术要求
Approval Department
Jilin Provincial Drug Administration
吉林省药品监督管理局
Registration Information
Registration Number
吉械注准20242400607
Approval Date
September 12, 2024
Expiry Date
September 11, 2029
Registrant
Name
Dirui Industrial Co., Ltd.
迪瑞医疗科技股份有限公司
Province/Region
Jilin
吉林
Address
No. 95, Yunhe Street, Changchun High-tech Industrial Development Zone
长春市高新技术产业开发区云河街95号
Production Facility
Production Address
长春市高新技术产业开发区云河街95号
Structure and Composition
English

Kit composition Main components Concentration Reagent 1(R1) phosphate buffer ≥10mmol/L Reagent 2(R2) Anti-human complement C1q serum ≥100mL/L Calibrator solution containing complement C1q see label Controls for complement C1q-containing solutions See label

中文

试剂盒组成 主要组成成分 浓度 试剂1(R1) 磷酸盐缓冲液 ≥10mmol/L 试剂2(R2) 抗人补体C1q血清 ≥100mL/L 校准品 含补体C1q的溶液 见标签 质控品 含补体C1q的溶液 见标签

Additional Information
Appendix
产品技术要求