Fritsamine (FMN) calibrator
- Device class
- Class II
- Model specifications
- 1mL×1;1mL×31mL×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20242400141
- Approval date
- August 08, 2024
- Expiry date
- August 07, 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 fructosamine kit produced by our company to establish the calibration curve of the fructosamine detection system.
与本公司生产的果糖胺试剂盒配套使用，用于建立果糖胺检测系统的校准曲线。.
This product is a lyophilized powder made by adding fructosamine (glycosylated albumin) and preservatives to a phosphate buffered saline matrix. Fructosamine (glycosylated albumin) concentration range: 250μmol/L~1145μmol/L.
本产品是在磷酸盐缓冲液基质中添加果糖胺（糖化白蛋白）、防腐剂等制成的冻干粉。果糖胺（糖化白蛋白）浓度范围：250μmol/L～1145μmol/L。.
Store in the dark at 2°C~8°C, valid for 15 months.
避光储存于2℃～8℃，有效期15个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Fritsamine (FMN) 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20242400141 and owned by InTec Products, INC.. The device was approved on August 08, 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.