Retinol binding protein determination reagent kit (latex immunoturbidimetric assay) - NMPA Registration 苏械注准20232400879
Access comprehensive regulatory information for Retinol binding protein determination reagent kit (latex immunoturbidimetric assay) 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20232400879 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on June 21, 2023.
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It is used for the quantitative determination of the content of retinol-binding protein in human serum and urine in vitro.
用于体外定量测定人血清、尿液中视黄醇结合蛋白的含量。
Reagent 1 (R1): phosphate buffer 0.1mol/L, macrogol 6000 20g/L Reagent 2 (R2): sheep anti-human retinol-binding protein antibody latex granule 0.3%, phosphate buffer 0.1mol/L calibrator (serum mode): retinol-binding protein (recombinant protein) (120~160) mg/L, phosphate buffer 0.1mol/L calibrator (urine mode): retinol-binding protein (recombinant protein) (8~12) mg/L, Phosphate buffer 0.1mol/L quality control (serum mode): retinol-binding protein (recombinant protein) level 1: (40~60) mg/L Level 2: (70~90) mg/L, phosphate buffer 0.1mmol/L control (urine mode): Retinol-binding protein (recombinant protein) level 1: (0.5~2) mg/L Level 2: (3~8) mg/L, phosphate buffer 0.1mol/L
试剂1（R1）:磷酸盐缓冲液0.1mol/L、聚乙二醇6000 20g/L试剂2（R2）：羊抗人视黄醇结合蛋白抗体胶乳颗粒0.3%、磷酸盐缓冲液0.1mol/L校准品（血清模式）：视黄醇结合蛋白（重组蛋白）（120~160）mg/L、磷酸盐缓冲液0.1mol/L校准品（尿液模式）：视黄醇结合蛋白（重组蛋白）（8~12）mg/L、磷酸盐缓冲液0.1mol/L质控品（血清模式）：视黄醇结合蛋白（重组蛋白）水平1：（40~60）mg/L 水平2：（70~90）mg/L、磷酸盐缓冲液0.1mmol/L质控品（尿液模式）：视黄醇结合蛋白（重组蛋白）水平1：（0.5~2）mg/L 水平2：（3~8）mg/L、磷酸盐缓冲液0.1mol/L
1. The kit is stored in 2 °C ~ 8 °C in the dark, the validity period is 18 months, and the reagent is stored in the dark at 2 °C ~ 8 °C after opening, the validity period is 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。