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低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法) - NMPA Registration 京械注准20242400675

Access comprehensive regulatory information for 低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400675 and owned by Beijing Strong Biotechnologies,Inc.. The device was approved on November 12, 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20242400675
低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法)
低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法)
NMPA Registration Number: 京械注准20242400675
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Intended Use
English

This kit is used for the in vitro quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma.

中文

本试剂盒用于体外定量测定人血清或血浆中低密度脂蛋白胆固醇(LDL-C)的含量。

Device Classification
Device Class
Class II
Model Specifications
610测试/盒;586测试/盒;试剂1:2;55mL、试剂2:2;22mL;试剂1:2;53mL、试剂2:2;21mL.质控品(水平1):1;1mL.质控品(水平2):1;1mL.
610测试/盒;586测试/盒;试剂1:2;55mL、试剂2:2;22mL;试剂1:2;53mL、试剂2:2;21mL。质控品(水平1):1;1mL。质控品(水平2):1;1mL。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400675
Approval Date
November 12, 2024
Expiry Date
November 11, 2029
Registrant
Name
Beijing Strong Biotechnologies,Inc.
北京九强生物技术股份有限公司
Province/Region
Beijing
北京
Address
5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
北京市海淀区花园东路15号旷怡大厦5层
Production Facility
Production Address
北京市怀柔区雁栖经济开发区雁栖北二街15号
Structure and Composition
English

Note: The target batch of the control is specific, see the target value list for details.

中文

注:质控品靶值批特异,详见靶值单。

Storage Conditions and Expiration
English

2 °C ~ 8 °C sealed and protected from light, valid for 18 months.

中文

2℃~8℃密封避光保存,有效期18个月。

Additional Information
Appendix
产品技术要求、说明书