Creatine kinase isoenzyme calibration solution
- Device class
- Class II
- Model specifications
- 1.0mL; 1.1.0mL;1。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400451
- 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
This product is used in conjunction with the creatine kinase MB isoenzyme assay kit (immunosuppressive method) produced by the company for the calibration of the test system of this 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，用于该项目检验系统的校准。
Lyophilized powder, recombinant creatine kinase isoenzyme, BSAA antimicrobial < 0.25% in serum matrix. Labeled value range: 80U/L~120U/L. The calibrator concentration is batch-specific, and the specific concentration is shown on the bottle label.
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%。标示值范围：80U/L～120U/L。校准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 calibration solution 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20242400451 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.