Glycated hemoglobin quality control material
- Device class
- Class II
- Model specifications
- 2×0.1mL/盒，2×0.3mL/盒，2×0.5mL/盒（内含水平1、水平2）
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252400162
- 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）
与深圳普门科技股份有限公司的糖化血红蛋白（HbA1c）测定试剂盒（高效液相色谱法）、糖化血红蛋白（HbA1c）测定试剂盒（液相色谱离子交换层析法）、糖化血红蛋白（HbA1c）分析用洗脱液（高效液相色谱法）、或糖化血红蛋白测定试剂盒（高效液相色谱法）配合使用，用于人全血中糖化血红蛋白（HbA1c）项目检测时的室内质量控制。
主要由糖化血红蛋白（人全血）、硫酸庆大霉素（防腐剂）组成。
1、2～8℃避光储存，有效期24个月。 2、本品开瓶复溶分装后，储存于-20℃条件下的稳定期为30天，仅可冻融1次。
- 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 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 粤械注准20252400162 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.