Glycated Hemoglobin Detection Kit (High Performance Liquid Chromatography Method) - NMPA Registration 粤械注准20252400161
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20252400161 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.
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。