Urine transferrin determination reagent kit (latex enhanced immunoturbidimetric method) - NMPA Registration 苏械注准20232400862
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.
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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。