Electrolyte (Na—K—Cl) Assay Kit (Dry Electrochemistry) - NMPA Registration 粤械注准20232401965
Access comprehensive regulatory information for Electrolyte (Na—K—Cl) Assay Kit (Dry Electrochemistry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20232401965 and owned by Labnovation Technologies,inc.. The device was approved on November 27, 2023.
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It is used to quantitatively detect the content of potassium ions in human serum/plasma/whole blood, and is mainly used for the auxiliary diagnosis of potassium metabolism disorders in clinical practice. It is used to quantitatively detect the content of sodium ions in human serum/plasma/whole blood, and is mainly used for the auxiliary diagnosis of sodium metabolism disorders in clinical practice. It is used to quantitatively detect the chlorine content in human serum/plasma/whole blood, and is mainly used in the auxiliary diagnosis of hyperchloremia or hypochloremia in clinical practice.
用于定量检测人体血清/血浆/全血中钾离子的含量，临床上主要用于钾代谢紊乱的辅助诊断。 用于定量检测人体血清/血浆/全血中钠离子的含量，临床上主要用于钠代谢紊乱的辅助诊断。 用于定量检测人体血清/血浆/全血中氯的含量，临床上主要用于高氯血症或低氯血症的辅助诊断。
It is mainly composed of electrolyte determination dry tablets and reference solution. The electrolyte determination dry slide is composed of a basal electrode, an ion-selective membrane, a salt bridge, a loose porous material, and a stuck shell. The reference solution is an aqueous solution containing sodium, potassium and chloride ions.
主要由电解质测定干片及参比液组成。 其中电解质测定干片由基础电极、离子选择膜、盐桥、疏松的多孔材料和卡壳组成。参比液为含有钠离子、钾离子、氯离子的水溶液。
When unopened, store at 2°C~8°C and have an expiration date of 18 months. In unopened condition, it can be stabilized to the date shown on the package. Electrolyte Determination Dry tablets should be tested within 1 hour after opening (under the conditions of room temperature (18°C~28°C) and conventional humidity (40%-60%RH)), and the reference solution should be placed in a refrigerated environment (2°C-8°C) sealed and stored after opening, and should be discontinued after 30 days of opening. The date of manufacture and the expiration date are shown on the outer box label.
未开封时，在 2℃～8℃条件下储存，有效期为 18 个月。在未打开包装的条件下，可以稳定到包装上所示日期。电解质测定干片开封后（室温（18℃～28℃）、常规湿度（40%-60%RH）条件下）应于1 小时内测试，参比液开瓶后将其置于冷藏环境（2℃-8℃）密封储存，应在开瓶 30 天后停止使用。生产日期及使用期限见外包装盒标签。