免疫球蛋白A(IgA)测定试剂盒(定时散射比浊法) - NMPA Registration 粤械注准20242401425
Access comprehensive regulatory information for 免疫球蛋白A(IgA)测定试剂盒(定时散射比浊法) 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20242401425 and owned by Genrui Biotech Inc.. The device was approved on October 25, 2024.
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 for the quantitative determination of immunoglobulin A (IgA) content in human serum or plasma in vitro, and is mainly used for the evaluation of immune function and the auxiliary diagnosis of immune diseases in clinical practice.
用于体外定量测定人血清或血浆中免疫球蛋白A（IgA）的含量，临床上主要用于免疫功能的评价及免疫疾病的辅助诊断。
1.缓冲液:磷酸盐缓冲液20 mmol/L,防腐剂0.1%;2.抗血清:抗人IgA抗体,防腐剂0.1%;3.稀释液:氯化钠0.9%,防腐剂0.1%;4.质控品(选配):IgA 抗原稀释于含BSA的PBS缓冲液;5.校准品(选配):IgA 抗原稀释于含BSA的PBS缓冲液;6.磁卡:载入本批次试剂的定标曲线信息.
1.缓冲液：磷酸盐缓冲液20 mmol/L，防腐剂0.1%；2.抗血清：抗人IgA抗体，防腐剂0.1%；3.稀释液：氯化钠0.9%，防腐剂0.1%；4.质控品（选配）：IgA 抗原稀释于含BSA的PBS缓冲液；5.校准品（选配）：IgA 抗原稀释于含BSA的PBS缓冲液；6.磁卡：载入本批次试剂的定标曲线信息。
未开封稳定性:避光储存于2-8℃,可保存12个月,不可冷冻.开封后稳定性:每次使用后立即盖紧盖子,保存于2-8℃,可稳定30天.在机稳定性:PA120开机状态下,试剂开封后抗血清在机2-15℃,缓冲液、稀释液在机2-30℃,可稳定7天.其他适用仪器开机状态下,试剂开封后在机2-15℃,可稳定7天.
未开封稳定性：避光储存于2-8℃，可保存12个月，不可冷冻。开封后稳定性：每次使用后立即盖紧盖子，保存于2-8℃，可稳定30天。在机稳定性：PA120开机状态下，试剂开封后抗血清在机2-15℃，缓冲液、稀释液在机2-30℃，可稳定7天。其他适用仪器开机状态下，试剂开封后在机2-15℃，可稳定7天。