Sodium, potassium, and chloride ion concentration detection quality control product (ion-selective electrode method)
- Device class
- Class II
- Model specifications
- 质控品水平1（正常数值）：10mL/瓶 质控品水平2（异常高数值）：10mL/瓶 质控品水平3（异常低数值）：10mL/瓶
- Approval department
- Jilin Provincial Drug Administration吉林省药品监督管理局
- Registration number
- 吉械注准20252400062
- 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
适用于附电解质分析装置的本集团的全自动生化分析仪，用于体外定量测定人血清和尿液中的钠、钾、氯离子浓度时的质量控制。
质控品水平1 氯化钠80-120mmol/L、磷酸二氢钠30-60mmol/L、氯化钾3.0-5.0mmol/L、普诺西林3001mmol/L、质控品水品2 氯化钠80-150mmol/L、磷酸二氢钠30-90mmol/L、氯化钾3.0-10mmol/L、普诺西林3001mmol/L、质控品水品3 氯化钠60-120mmol/L、磷酸二氢钠10-60mmol/L、氯化钾1-5mmol/L、普诺西林3001mmol/L
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Sodium, potassium, and chloride ion concentration detection quality control product (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20252400062 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.