Ceruloplasmin quality control material
- Device class
- Class III
- Model specifications
- Low-value controls: 1×1mL; 1×3mL. High-value controls: 1×1mL; 1×3mL.低值质控品：1×1mL；1×3mL。高值质控品：1×1mL；1×3mL。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20223401234
- Approval date
- September 09, 2022
- Expiry date
- September 08, 2027
- Name
- Beijing Leadman Biochemistry Co., Ltd.北京利德曼生化股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing北京市北京经济技术开发区兴海路5号
- Production address
- 北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢
This product is used for quality control of ceruloplasmin testing items.
本产品用于铜蓝蛋白检测项目的质量控制。
Two levels of liquid controls. Contains phosphate buffer (10 mM), ceruloplasmin, sodium azide (0.01%).
两个水平的液态质控品。含磷酸盐缓冲液（10mM），铜蓝蛋白，叠氮钠（0.01%）。
Store at 2 °C ~ 8 °C, valid for 18 months.
在2℃～8℃保存，有效期为18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Ceruloplasmin quality control material in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20223401234 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on September 09, 2022.
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.