Microalbumin calibrator
- Device class
- Class II
- Model specifications
- 1mL×1;1mL×3.1mL×1；1mL×3。
- Approval department
- Fujian Provincial Drug Administration福建省药品监督管理局
- Registration number
- 闽械注准20242400134
- Approval date
- August 06, 2024
- Expiry date
- August 05, 2029
- Name
- InTec Products, INC.英科新创（厦门）科技股份有限公司
- Province/Region
- Fujian福建
- Address
- No. 332, Xinguang Road, Xiamen Xinyang Industrial Zone, Haicang厦门市海沧新阳工业区新光路332号
- Production address
- 厦门市海沧新阳工业区新光路332号；厦门市海沧新阳工业区翁角路308号8号和51号厂房
It is used in conjunction with the microalbumin kit produced by our company to establish the calibration curve of the microalbumin detection system.
与本公司生产的微量白蛋白试剂盒配套使用，用于建立微量白蛋白检测系统的校准曲线。.
This product is made with the addition of human-derived albumin, preservatives, etc. to a phosphate-buffered saline matrix. Albumin concentration range: 180 mg/L~220mg/L.
本产品是在磷酸盐缓冲液基质中添加人源性的白蛋白、防腐剂等。白蛋白浓度范围：180 mg/L～220mg/L。.
The original packaging is stored in 2°C~8°C under the condition of closed and dark storage, and the validity period is 21 months.
原包装在2℃～8℃条件下密闭避光贮存，有效期21个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Microalbumin calibrator in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 闽械注准20242400134 and owned by InTec Products, INC.. The device was approved on August 06, 2024.
This page provides complete registration details including registrant information, province location (Fujian), 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.