China NMPA legacy archive 粤械注准20252400162Glycated hemoglobin quality control material
糖化血红蛋白质控品
Shenzhen Lifotronic Technology Co., Ltd.Class IINMPAApproved January 24, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- 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 information
- Registration number
- 粤械注准20252400162
- Approval date
- January 24, 2025
- Expiry date
- January 23, 2030
Registrant
- Province/Region
- Guangdong
- Address
- Pumen Science and Technology Headquarters Building, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen
广东
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 facility
- 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）
Intended use
English
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。
Structure and composition
English
主要由糖化血红蛋白（人全血）、硫酸庆大霉素（防腐剂）组成。
Storage conditions and expiration
English
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。
Additional information
- 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
About this record
This static archive preserves historical registration fields and translations for Glycated hemoglobin quality control material, registration 粤械注准20252400162. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.