Glycated Hemoglobin Detection Kit (High Performance Liquid Chromatography Method)
- 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 number
- 粤械注准20252400144
- Approval date
- January 23, 2025
- Expiry date
- January 22, 2030
- Name
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.深圳迈瑞生物医疗电子股份有限公司
- Province/Region
- Guangdong广东
- Address
- Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen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 address
- 深圳市光明新区南环大道1203号
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。
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。
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。
- 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20252400144 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was approved on January 23, 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.