China NMPA legacy archive 粤械注准20252400161Glycated 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
- Registration number
- 粤械注准20252400161
- Approval date
- January 24, 2025
- Expiry date
- January 23, 2030
- Province/Region
- Guangdong
- Address
- Pumen Science and Technology Headquarters Building, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen
- 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
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