Glycated hemoglobin (HbA1c) quality control material
- Device class
- Class II
- Model specifications
- Level 1: 0.5 mL×1 Level 1: 0.5 mL×3 Level 2: 0.5 mL×1 Level 2: 0.5 mL×3 Level 1: 0.5 mL ×1, Level 2: 0.5 mL×1 Level 1: 0.5 mL×3, Level 2: 0.5 mL×3水平1：0.5mL×1 水平1：0.5mL×3 水平2：0.5mL×1 水平2：0.5mL×3 水平1：0.5mL×1，水平2：0.5mL×1 水平1：0.5mL×3，水平2：0.5mL×3
- Approval department
- Fujian Provincial Drug Administration福建省药品监督管理局
- Registration number
- 闽械注准20242400137
- 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 glycosylated hemoglobin kit manufactured by our company for in-house quality control of glycosylated hemoglobin detection systems.
与本公司生产的糖化血红蛋白试剂盒配套使用，用于糖化血红蛋白检测系统的室内质量控制。.
This product is a lyophilized powder made by adding hemoglobin, glycosylated hemoglobin, preservatives, etc. to a phosphate buffered saline matrix. Glycosylated hemoglobin concentration range: level 1: 2.0%~6.0%; Level 2: 6.0%~14.0%.
本产品是在磷酸盐缓冲液基质中添加血红蛋白、糖化血红蛋白、防腐剂等制成的冻干粉。糖化血红蛋白浓度范围：水平1：2.0%～6.0%；水平2：6.0%～14.0%.
The original packaging is stored at 2°C~8°C in the dark, and the validity period is 18 months.
原包装避光贮存于2℃～8℃，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Glycated hemoglobin (HbA1c) quality control material 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20242400137 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.