Sodium, potassium, chloride ion concentration detection calibration solution (ion selective electrode method)
- Device class
- Class II
- Model specifications
- 校准品A：520mL/袋 校准品B：190mL/袋
- Approval department
- Jilin Provincial Drug Administration吉林省药品监督管理局
- Registration number
- 吉械注准20252400061
- Approval date
- January 21, 2025
- Expiry date
- January 20, 2030
- Name
- Jilin Base Egg Biological Technology Co., Ltd.吉林基蛋生物科技有限公司
- Province/Region
- Jilin吉林
- Address
- No. 1399, Ya'an Road, Beihu Science and Technology Development Zone, Changchun City, Jilin Province吉林省长春市北湖科技开发区雅安路1399号
- Production address
- 吉林省长春市北湖科技开发区雅安路1399号
适用于本集团生产的附电解质分析装置的全自动生化分析仪，测定人血清和尿液中的钠、钾、氯离子浓度时，通过将校准品A和校准品B组合进行测定，以获得离子选择电极的斜率值。
校准品A 氯化钠120mmol/L、磷酸二氢钠20mmol/L、氯化钾4.0mmol/L、普诺西林3001mmol/L、校准品B 氯化钠32.6mmol/L、磷酸二氢钠37.4mmol/L、氯化钾8.0mmol/L、普诺西林3001mmol/L
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Sodium, potassium, chloride ion concentration detection calibration solution (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 吉械注准20252400061 and owned by Jilin Base Egg Biological Technology Co., Ltd.. The device was approved on January 21, 2025.
This page provides complete registration details including registrant information, province location (Jilin), 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.