Sodium, potassium, chloride electrolyte detection reagent kit (ion selective electrode method) - NMPA Registration 鲁械注准20222401101
Access comprehensive regulatory information for Sodium, potassium, chloride electrolyte detection reagent kit (ion selective electrode 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 鲁械注准20222401101 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on September 06, 2022.
This page provides complete registration details including registrant information, province location (Shandong), 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.
It is used to quantitatively detect the concentration of sodium, potassium and chloride ions in human serum samples.
用于定量检测人血清样本中钠、钾、氯离子的浓度。
Main components: Reference solution: potassium chloride (75mmol/L); Dilution: trimethylolaminomethane buffer (35mmol/L), triethanolamine (17mmol/L), boric acid (15mmol/L); Internal standard solution: trimethylolaminomethane buffer (55mmol/L), triethanolamine (15mmol/L), sodium chloride (1.5g/L), sodium acetate (0.8g/L), potassium chloride (0.5g/L), boric acid (30mmol/L); Calibrator H: sodium chloride (120mmol/L), potassium dihydrogen phosphate (7mmol/L); Calibrator M: sodium chloride (103mmol/L), potassium chloride (5mmol/L); Calibrator L: sodium chloride (80mmol/L), potassium dihydrogen phosphate (3mmol/L).
主要组成成分： 参比液：氯化钾（75mmol/L）； 稀释液：三羟甲基氨基甲烷缓冲液（35mmol/L）、三乙醇胺（17mmol/L）、硼酸（15mmol/L）； 内标液：三羟甲基氨基甲烷缓冲液（55mmol/L）、三乙醇胺（15mmol/L）、氯化钠（1.5g/L）、醋酸钠（0.8g/L）、氯化钾（0.5g/L）、硼酸（30mmol/L）； 校准品H：氯化钠（120mmol/L）、磷酸二氢钾（7mmol/L）； 校准品M：氯化钠（103mmol/L）、氯化钾（5mmol/L）； 校准品L：氯化钠（80mmol/L）、磷酸二氢钾（3mmol/L）。
1. Reference solution, diluent, internal standard solution are stored at 2°C-26°C, avoid high temperature and direct sunlight, and the validity period is 12 months; Standard H, Standard L, and calibrators are stored at 2°C-8°C for 12 months. 2. The reference solution, diluent solution and internal standard solution are stored at 2°C-26°C after opening, and the validity period is 4 weeks; Standard solution H, standard solution L, and the calibrator are stored in a dark seal at 2°C-8°C after the first opening, and the validity period is 1 week without pollution.
1.参比液、稀释液、内标液于2℃-26℃储存，避免高温和日光直射，有效期为12个月；标准液H、标准液L、校准品于2℃-8℃储存，有效期为12个月。 2.参比液、稀释液、内标液开瓶后于2℃-26℃储存，有效期均为4周；标准液H、标准液L、校准品首次开封后避光密封保存于2℃-8℃，在无污染情况下有效期均为1周。