Creatine kinase isoenzyme quality control product
- Device class
- Class II
- Model specifications
- Level 1: 1.0 mL; Level 2: 1.0mL; 1.水平1：1.0mL;1；水平2：1.0mL;1。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400452
- Approval date
- August 27, 2024
- Expiry date
- August 26, 2029
- Name
- Beijing WantaiDerui Diagnostic Technology Co., Ltd.北京万泰德瑞诊断技术有限公司
- Province/Region
- Beijing北京
- Address
- No. 31 Science Park Road, Changping District, Beijing北京市昌平区科学园路31号
- Production address
- 北京市昌平区科学园路31号1号楼1层102和106，1号楼3层A区、B区、C区，7号楼东侧303、西侧401
The product is used in conjunction with the creatine kinase MB isoenzyme assay kit (immunosuppressive method) produced by the company for in-house quality control of the project.
该产品与该公司生产的肌酸激酶MB同工酶测定试剂盒(免疫抑制法）配套使用，用于该项目的室内质量控制。
冻干粉,在血清基质中添加重组的肌酸激酶同工酶,BSAA抗菌剂<0.25%. 质控品水平1靶值范围:20U/L~50U/L,质控品水平2靶值范围:80U/L~120U/L. 质控品浓度具有批特异性,具体浓度见瓶签.
冻干粉，在血清基质中添加重组的肌酸激酶同工酶，BSAA抗菌剂＜0.25%。质控品水平1靶值范围：20U/L～50U/L，质控品水平2靶值范围：80U/L～120U/L。质控品浓度具有批特异性，具体浓度见瓶签。
2°C~8°C Protected from light and stored in a closed manner, with a validity period of 24 months.
2℃~8℃避光密闭保存，有效期为24个月。
Access comprehensive regulatory information for Creatine kinase isoenzyme quality control product 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20242400452 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on August 27, 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.