High-density lipoprotein cholesterol test kit (direct method - peroxidase clearing method)
- 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 number
- 京械注准20242400673
- Approval date
- November 12, 2024
- Expiry date
- November 11, 2029
- 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 address
- 北京市怀柔区雁栖经济开发区雁栖北二街15号
This kit is used for the in vitro quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma.
本试剂盒用于体外定量测定人血清或血浆中高密度脂蛋白胆固醇（HDL-C）的含量。
Note: The target batch of the control is specific, see the target value list for details.
注：质控品靶值批特异，详见靶值单。
2 °C ~ 8 °C sealed and protected from light, valid for 18 months.
2℃~8℃密封避光保存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for High-density lipoprotein cholesterol test kit (direct method - peroxidase clearing 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20242400673 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.