Urine transferrin determination reagent kit (latex enhanced immunoturbidimetric method)
- Device class
- Class II
- Model specifications
- See annex见附件
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20232400862
- Approval date
- June 19, 2023
- Expiry date
- June 18, 2028
- Name
- Ali Biotech Taizhou Co., Ltd.阿里生物技术泰州有限公司
- Province/Region
- Jiangsu江苏
- Address
- Taizhou National Pharmaceutical High-tech Industrial Park, west of Taizhou Medical City, west of Tai Road, east of Building 0007, G61, East of Lujia Road, east of the first to fourth floors泰州国家医药高新技术产业园中国医药城口泰路西侧、陆家路东侧0007幢G61号一至四层东侧
- Production address
- 泰州中国医药城口泰路西侧、陆家路东侧0007幢61号一至四层东侧
It is used for the quantitative determination of the content of transferrin in human urine in vitro.
用于体外定量测定人尿液中转铁蛋白的含量。
Reagent 1 (R1): phosphate buffer 100mmol/L, sodium chloride 9g/L, polyethylene glycol 6000 20g/L Reagent 1 (R2): latex granules coated with sheep anti-human transferrin 0.3g/L, phosphate buffer 100mmol/L, sodium chloride 9g/L calibrator: transferrin (human) 40~70mg/L, phosphate buffer 100mmol/L, bovine serum albumin 10g/L Quality control: transferrin (human) level 1:1~3mg/L level 2: 4~8mg/L, phosphate buffer 100mmol/L, bovine serum albumin 10g/L
试剂1（R1）：磷酸盐缓冲液 100mmol/L、氯化钠9g/L、聚乙二醇6000 20g/L试剂1（R2）：包被有羊抗人转铁蛋白的乳胶颗粒0.3g/L、磷酸盐缓冲液 100mmol/L、氯化钠9g/L校准品：转铁蛋白（人源） 40~70mg/L、磷酸盐缓冲液 100mmol/L、牛血清白蛋白 10g/L质控品：转铁蛋白（人源） 水平1：1~3mg/L水平2：4~8mg/L、磷酸盐缓冲液 100mmol/L、牛血清白蛋白 10g/L
1. The kit is stored in the dark at 2 °C ~ 8 °C with a validity period of 18 months, and the reagent is stored in the dark at 2 °C ~ 8 °C after opening, with a validity period of 30 days. 2. Calibrators and quality control products are stored in 2 °C ~ 8 °C in the dark, the validity period is 18 months, after opening the bottle at 2 °C ~ 8 °C in the dark, the validity period is 7 days.
1.试剂盒在2℃~8℃避光保存，有效期18个月，试剂开瓶后在2℃~8℃避光保存，有效期30天。2.校准品和质控品在2℃~8℃避光保存，有效期18个月，开瓶后在2℃~8℃避光保存，有效期7天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Urine transferrin determination reagent kit (latex enhanced immunoturbidimetric 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 苏械注准20232400862 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on June 19, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.