Glycated hemoglobin quality control material - NMPA Registration 渝械注准20242400382
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 渝械注准20242400382 and owned by Zybio Inc.. The device was approved on September 27, 2024.
This page provides complete registration details including registrant information, province location (Chongqing), 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.
This product is used with the glycosylated hemoglobin detection kit (dry immunofluorescence method) produced by Zhongyuan Huiji Biotechnology Co., Ltd. for the quality control of the glycosylated hemoglobin (HbA1c) detection system.
本产品配套中元汇吉生物技术股份有限公司生产的糖化血红蛋白检测试剂盒（干式免疫荧光法）使用，用于糖化血红蛋白（HbA1c）检测系统的质量控制。
This product is a lyophilized quality control. (Please refer to the product manual for details)
本产品为冻干质控品。（具体内容详见产品说明书）
1. This product is sealed and stored at 2°C~8°C, and the validity period is 6 months. 2. This product can be stored at 2°C~8°C for 8 hours after reconstitution; It can be stored at -25°C~-15°C for 30 days, and the number of repeated freeze-thaw is not more than 3 times.
1.本品2℃～8℃密封保存，有效期为6个月。2.本产品复溶后在2℃～8℃可保存8小时；在-25℃～-15℃可保存30天，反复冻融次数不大于3次。