转铁蛋白(TRF)测定试剂盒(定时散射比浊法) - NMPA Registration 粤械注准20242401509
Access comprehensive regulatory information for 转铁蛋白(TRF)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20242401509 and owned by Genrui Biotech Inc.. The device was approved on November 11, 2024.
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This kit is used for the in vitro quantitative determination of transferrin (TRF) content in human serum or urine. Clinically, it is mainly used for the auxiliary diagnosis of iron deficiency, liver and other diseases.
本试剂盒用于体外定量测定人血清或者尿液中转铁蛋白（TRF）的含量。临床上主要用于铁缺乏症、肝脏等疾病的辅助诊断。
1 缓冲液:磷酸盐缓冲液20 mmol/L、氯化钠15.8 g/L、聚乙二醇6000(PEG6000)4%、防腐剂0.1%; 2 抗血清:羊抗人转铁蛋白特异性抗体偶联的乳胶颗粒0.1%; 3 质控品(选配):含TRF抗原稀释于5%BSA-PBS缓冲液,具体靶值见瓶贴; 4 校准品(选配):含TRF抗原稀释于5%BSA-PBS缓冲液,具体靶值见瓶贴; 5 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、氯化钠15.8 g/L、聚乙二醇6000（PEG6000）4%、防腐剂0.1%； 2 抗血清：羊抗人转铁蛋白特异性抗体偶联的乳胶颗粒0.1%； 3 质控品（选配）：含TRF抗原稀释于5%BSA-PBS缓冲液，具体靶值见瓶贴； 4 校准品（选配）：含TRF抗原稀释于5%BSA-PBS缓冲液，具体靶值见瓶贴； 5 磁卡：载入本批次试剂的定标曲线信息。
Before the kit is opened, all reagents should be stored at 2-8°C protected from light for 12 months and should not be frozen. The kit is stored at 2-8°C after opening and can be stable for 30 days; Reagent buffer and antiserum are on machine (2-15 °C) after opening, valid for 7 days.
试剂盒未开启前，所有试剂避光储存于2-8℃，可保存12个月，不可冷冻。试剂盒开启后保存于2-8℃，可稳定30天；试剂缓冲液和抗血清开封后在机（2-15℃），有效期7天。