Urinary Sediment Analysis Quality Control Solution
- Device class
- Class II
- Model specifications
- Positive control fluid levels 1:1×20mL, 1×60mL, 1×125mL Positive control fluid levels are 2: 1×20 mL, 1×60 mL, 1×125 mL Negative quality control solution: 1×20mL, 1×60mL, 1×125mL阳性质控液水平1：1×20mL、1×60mL、1×125mL 阳性质控液水平2：1×20mL、1×60mL、1×125mL 阴性质控液：1×20mL、1×60mL、1×125mL
- Approval department
- Jilin Provincial Drug Administration吉林省药品监督管理局
- Registration number
- 吉械注准20242400008
- Approval date
- January 25, 2024
- Expiry date
- January 24, 2029
- 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
It is used for quality control of the testing process of urine tangible analytical instruments.
用于尿有形分析仪器测试过程的质量控制。
Positive control fluid level 1: porcine red blood cells, 300 particles/μL ~ 700 particles/μL Positive control fluid level 2: porcine red blood cells, 900 particles/μL ~ 1300 particles/μL Negative quality control solution: disodium hydrogen phosphate, 6.5mmol/L
阳性质控液水平1：猪血红细胞，300粒子/µL ～700粒子/µL 阳性质控液水平2：猪血红细胞，900粒子/µL ～1300粒子/µL 阴性质控液：磷酸氢二钠，6.5mmol/L
Under the condition of 2 °C ~ 8 °C, protect from light, sealed storage, and the validity period is 8 months. After the first opening, it can be stored at 2°C~8°C in the dark, sealed, and can be stable for 30 days.
在2℃~8℃条件下，避光、密封贮存，有效期为8个月。首次开封后，2℃~8℃避光、密封保存，可稳定30天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Urinary Sediment Analysis Quality Control Solution 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20242400008 and owned by Jilin Base Egg Biological Technology Co., Ltd.. The device was approved on January 25, 2024.
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.