Creatine Kinase Isoenzyme Determination Reagent Kit (Immune Inhibition Method) - NMPA Registration 苏械注准20232400788
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.
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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。