Glutathione Reductase Assay Kit (Glutathione Substrate Method) - NMPA Registration 粤械注准20252400027
Access comprehensive regulatory information for Glutathione Reductase Assay Kit (Glutathione Substrate 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20252400027 and owned by Shenzhen New Industries Biomedical Engineering Co., Ltd.. The device was approved on January 08, 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.
本试剂盒用于体外定量测定人血清或血浆中谷胱甘肽还原酶的活性。临床上用于葡萄糖-6磷酸脱氢酶（G-6-PD）缺乏症的辅助诊断。
由R1、R2、校准品（选配）、质控品（选配）组成。 R1：氧化谷胱甘肽、Bis-Tris丙烷-HCl缓冲液、防腐剂； R2：NADPH、碳酸盐缓冲液、防腐剂； 校准品（选配）：谷胱甘肽还原酶、PBS缓冲液、BSA、防腐剂； 质控品（选配）：谷胱甘肽还原酶、PBS缓冲液、BSA、防腐剂。
1.货架效期：未开瓶的试剂、产品校准品、质控品在2℃～8℃条件下保存，效期为18个月。 2.使用效期：试剂机载（2℃～15℃）有效期为14天。试剂开瓶后在2℃～8℃条件下可保存28天。产品校准品、质控品开瓶后在10℃～30℃条件下可保存24小时。产品校准品、质控品开瓶后在2℃～8℃条件下可保存15天。产品校准品、质控品开瓶后在-20℃条件下可保存3个月。产品校准品、质控品冻融不超过1次。