Creatine kinase determination reagent kit (N-acetyl cysteine method) - NMPA Registration 滇械注准20162400085
Access comprehensive regulatory information for Creatine kinase determination reagent kit (N-acetyl cysteine 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 滇械注准20162400085 and owned by Yunnan Haoxu Biotechnology Co., Ltd.. The device was approved on September 27, 2021.
This page provides complete registration details including registrant information, province location (Yunnan), 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.
For in vitro quantitative determination of creatine kinase in human serum or plasma.
用于人血清或血浆中肌酸激酶的体外定量测定。
"R1: Imidazole buffer (pH 6.6) 100×10-3mol/L, adenosine diphosphate 2×10-3mol/L, adenosine monophosphate 5×10-3mol/L, N-acetylcysteine 20×10-3mol/L, ethylenediaminetetraacetic acid 2.0×10-3mol/L, magnesium acetate 10×10-3mol/L, glucose 6-phosphate dehydrogenation 2400 U/L, oxidative coenzyme II.2×10-3 mol/L, glycokinase 3000U / L, D-glucose 0.03mol/L R2: creatine phosphate 30×10-3mol/L "
"R1：咪唑缓冲剂(pH6.6) 100×10-3mol/L、二磷酸腺苷2×10-3mol/L、单磷酸腺苷5×10-3mol/L、N-乙酰半胱氨酸20×10-3mol/L、乙二胺四乙酸2.0×10-3mol/L、醋酸镁10×10-3mol/L、6-磷酸葡萄糖脱氢2400U/L、氧化性辅酶Ⅱ2×10-3mol/L、已糖激酶3000U/L、 D-葡萄糖0.03mol/L R2：磷酸肌酸30×10-3mol/L "
"The kit is stored at 2~8 °C, and it can be stable for one year in the dark. After opening the reagent, pay attention to avoid contamination, 2~8 °C can be stable for one week, it is recommended to finish as soon as possible. "
"试剂盒贮存在2～8℃下，避光保存可稳定一年。 试剂开瓶后注意避免污染，2～8℃可稳定一周，建议尽快完。 "