Creatine Kinase Isoenzyme Determination Reagent Kit (Immune Inhibition Method)
- Device class
- Class II
- Model specifications
- See annex见附件
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20232400788
- Approval date
- June 19, 2023
- Expiry date
- June 04, 2028
- Name
- Ali Biotech Taizhou Co., Ltd.阿里生物技术泰州有限公司
- Province/Region
- Jiangsu江苏
- Address
- Taizhou National Pharmaceutical High-tech Industrial Park, west of Taizhou Medical City, west of Tai Road, east of Building 0007, G61, East of Lujia Road, east of the first to fourth floors泰州国家医药高新技术产业园中国医药城口泰路西侧、陆家路东侧0007幢G61号一至四层东侧
- Production address
- 泰州中国医药城口泰路西侧、陆家路东侧0007幢61号一至四层东侧
For in vitro quantitative determination of creatine kinase isoenzyme activity in human serum.
用于体外定量测定人血清中肌酸激酶同工酶的活性。
Reagent 1 (R1): Magnesium acetate 10mmol/L, N-acetylcysteine (NAC) 20g/L, creatine phosphate 30mmol/L, D-glucose 20mmol/L, imidazole buffer 100mmol/L, sheep anti-human CK-M serum 6ml/L, ethylenediaminetetraacetic acid (EDTA) 2g/L Reagent 2 (R2): 2-amino-2-methyl-1-propanol buffer (AMP buffer) 5mmol/L, glucose-6 phosphatase (G6PD) 2000U/L, phosphocreatine (AP5A) 10g/L, hexokinase 3000U/L, adenosine diphosphate (ADP) 2mmol/L, oxidative coenzyme 2 (NADP+) 2mmol/L
试剂1（R1）：醋酸镁 10mmol/L、N-乙酰半胱氨酸（NAC） 20g/L、磷酸肌酸 30mmol/L、D-葡萄糖 20mmol/L、咪唑缓冲液 100mmol/L、羊抗人CK-M血清 6ml/L、乙二胺四乙酸(EDTA) 2g/L试剂2（R2）:2氨基-2-甲基-1-丙醇缓冲液（AMP缓冲液） 5mmol/L、葡萄糖6磷酸酶(G6PD) 2000U/L、磷酸肌酸（AP5A） 10g/L、己糖激酶3000U/L、二磷酸腺苷(ADP) 2mmol/L、氧化性辅酶2(NADP+) 2mmol/L
The reagent is stored in 2 °C ~ 8 °C in the dark, the validity period is 18 months, and it can be stable for 30 days after opening the bottle at 2 °C ~ 8 °C in the dark.
试剂在2℃~8℃避光保存，有效期18个月，开瓶后在2℃～8℃避光保存可稳定30天。
- Remark
- 本文件与“苏械注准20232400788”注册证共同使用
- Changes
- 2023-06-19生产地址变更 由“泰州中国医药城口泰路西侧、陆家路东侧0007幢G61号一至四层东侧”变更为“泰州中国医药城口泰路西侧、陆家路东侧0007幢61号一至四层东侧”
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Creatine Kinase Isoenzyme Determination Reagent Kit (Immune Inhibition 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 苏械注准20232400788 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on June 19, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.