China NMPA legacy archive 国械注准20223401234Ceruloplasmin quality control material
铜蓝蛋白质控品
Beijing Leadman Biochemistry Co., Ltd.Class IIINMPAApproved September 09, 2022
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- Low-value controls: 1×1mL; 1×3mL. High-value controls: 1×1mL; 1×3mL.
- Approval department
- State Drug Administration
低值质控品：1×1mL；1×3mL。高值质控品：1×1mL；1×3mL。
国家药品监督管理局
Registration information
- Registration number
- 国械注准20223401234
- Approval date
- September 09, 2022
- Expiry date
- September 08, 2027
Registrant
- Province/Region
- Beijing
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京
北京市北京经济技术开发区兴海路5号
Production facility
- 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
Intended use
English
This product is used for quality control of ceruloplasmin testing items.
中文
本产品用于铜蓝蛋白检测项目的质量控制。
Structure and composition
English
Two levels of liquid controls. Contains phosphate buffer (10 mM), ceruloplasmin, sodium azide (0.01%).
中文
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%）。
Storage conditions and expiration
English
Store at 2 °C ~ 8 °C, valid for 18 months.
中文
在2℃～8℃保存，有效期为18个月。
Additional information
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for Ceruloplasmin quality control material, registration 国械注准20223401234. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.