转铁蛋白(TRF)测定试剂盒(定时散射比浊法)
- Device class
- Class II
- Model specifications
- 25人份/盒、50人份/盒、100人份/盒、150人份/盒、200人份/盒、250人份/盒、300人份/盒、400人份/盒,质控品S1/S2/S3(选配)、质控品U1/U2/U3(选配)、校准品S1/S2/S3(选配)、校准品U1/U2/U3(选配).25人份/盒、50人份/盒、100人份/盒、150人份/盒、200人份/盒、250人份/盒、300人份/盒、400人份/盒，质控品S1/S2/S3（选配）、质控品U1/U2/U3（选配）、校准品S1/S2/S3（选配）、校准品U1/U2/U3（选配）。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20242401509
- Approval date
- November 11, 2024
- Expiry date
- November 10, 2029
- Name
- Genrui Biotech Inc.深圳市锦瑞生物科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- Shenzhen Guangming New District Matian Street Ma Shantou Community Watch Base Geya Science and Technology Park Building 3 4 to 10 floors深圳市光明新区马田街道马山头社区钟表基地格雅科技园3栋4至10层
- Production address
- 深圳市光明新区马田办事处马山头社区钟表基地格雅科技园3栋4至10层；深圳市光明区玉塘街道玉律社区光侨大道1008号裕丰达工业园2栋901
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。
- Remark
- 本文件与“粤械注准20242401509”注册证共同使用。
- Changes
- 2024-11-14: 1、生产地址由“深圳市光明新区马田办事处马山头社区钟表基地格雅科技园3栋4至10层；深圳市光明区马田街道合水口社区第七工业区第三栋厂房A801；广东省东莞市黄江镇田星路39号2栋501室（仅为仓库使用）”变更为“深圳市光明新区马田办事处马山头社区钟表基地格雅科技园3栋4至10层；深圳市光明区玉塘街道玉律社区光侨大道1008号裕丰达工业园2栋901”。
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.
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.