Retinol binding protein determination reagent kit (latex immunoturbidimetric assay)
- 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20232400879
- Approval date
- June 21, 2023
- Expiry date
- June 20, 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 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。
- Appendix
- 产品技术要求、说明书
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.
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.