China NMPA legacy archive 粤械注准20252400144Glycated Hemoglobin Detection Kit (High Performance Liquid Chromatography Method)
糖化血红蛋白测定试剂盒（高效液相色谱法）
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Class IINMPAApproved January 23, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- H-12A 洗脱液：1.5 L×1；H-12B 洗脱液：250 mL×1、500 mL×1。
- Approval department
- Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
- Registration number
- 粤械注准20252400144
- Approval date
- January 23, 2025
- Expiry date
- January 22, 2030
Registrant
- Province/Region
- Guangdong
- Address
- Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen
广东
深圳市南山区高新技术产业园区科技南十二路迈瑞大厦1-4层
Production facility
- Production address
- 深圳市光明新区南环大道1203号
Intended use
English
用于定量检测全血中的糖化血红蛋白含量。临床上用于糖尿病的辅助诊断和血糖水平的监测。
Structure and composition
English
H-12A 洗脱液：柠檬酸盐、异噻唑啉酮类抑菌剂，H-12B 洗脱液：磷酸盐、异噻唑啉酮类抑菌剂。
Storage conditions and expiration
English
本品应储存在 2℃～30℃温度下，无腐蚀性气体和通风良好的室内，避免阳光直射。有效期为9个月。 开瓶使用温度为10℃～35℃，开瓶后使用有效期为100天。
Additional information
- 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 Detection Kit (High Performance Liquid Chromatography Method), registration 粤械注准20252400144. 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.