Glycated Hemoglobin Detection Kit (High Performance Liquid Chromatography Method)
- Device class
- Class II
- Model specifications
- 100测试/盒、200测试/盒、300测试/盒、400测试/盒、500测试/盒、800测试/盒、4×200测试/盒、8×200测试/盒、4×400测试/盒、7×400测试/盒
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252400161
- Approval date
- January 24, 2025
- Expiry date
- January 23, 2030
- Name
- Shenzhen Lifotronic Technology Co., Ltd.深圳普门科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- Pumen Science and Technology Headquarters Building, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen深圳市龙华区观湖街道观城社区求知东路8号普门科技总部大厦
- Production address
- 广东省东莞市松山湖园区彰化路2号1号厂房2-11楼（委托生产）
It is used to quantitatively detect the content of glycated hemoglobin (HbA1c) in human whole blood, and is mainly used clinically for the auxiliary diagnosis of diabetes and the monitoring of blood glucose levels.
用于定量检测人全血中糖化血红蛋白（HbA1c）的含量，临床上主要用于糖尿病的辅助诊断和血糖水平的监控。
洗脱液A（柠檬酸盐缓冲液）、洗脱液B（柠檬酸盐缓冲液）、洗脱液C（柠檬酸盐缓冲液）、溶血剂L（磷酸盐缓冲液)。
未开封试剂，在4～30℃条件下储存，有效期为24个月。 试剂在开封后，可在4～30℃保存3个月。
- Remark
- 受托生产企业：广东普门生物医疗科技有限公司；统一社会信用代码：91441900MA4UHLWH4C。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Glycated Hemoglobin Detection Kit (High Performance Liquid Chromatography 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 粤械注准20252400161 and owned by Shenzhen Lifotronic Technology Co., Ltd.. The device was approved on January 24, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.