Retinol Binding Protein (RBP) Determination Reagent Kit (Immunoturbidimetry) - NMPA Registration 粤械注准20242400526
Access comprehensive regulatory information for Retinol Binding Protein (RBP) Determination Reagent Kit (Immunoturbidimetry) 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20242400526 and owned by Shenzhen AmTech Bioengineering Ltd,Inc. The device was approved on April 15, 2024.
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It is used for the quantitative determination of the content of retinol-binding protein in human urine in vitro, and is mainly used for the auxiliary diagnosis of renal tubular injury in clinical practice.
用于体外定量测定人尿液中视黄醇结合蛋白的含量，临床上主要用于肾小管损伤的辅助诊断。
The kit consists of R1, R2, calibrator (optional), and quality control (optional), and the main components are as follows: 1. Reagent 1 (R1): trimethylolaminomethane (Tris) buffer, sodium azide. Reagent 2 (R2): latex suspension coated with retinol-binding protein antibody (rabbit origin). 3. Calibrators, quality controls: tris-hydroxymethylolaminomethane (Tris) buffer, retinol-binding protein antigen (recombinant), sodium azide.
试剂盒由R1、R2、校准品（选配）、质控品（选配）组成，主要成分如下： 1. 试剂1（R1）：三羟甲基氨基甲烷（Tris）缓冲液、叠氮化钠。 2. 试剂2（R2）：视黄醇结合蛋白抗体（兔源）包被的胶乳悬浊液。 3. 校准品、质控品：三羟甲基氨基甲烷（Tris）缓冲液、视黄醇结合蛋白抗原（重组）、叠氮化钠。
This kit (including calibrators and quality controls) should be stored at 2~8°C in the dark, forbidden to freeze, and the validity period is 18 months. After the reagent is opened, it can be stored at 4~15 °C in the dark and can be stable for 30 days. The calibrators and quality controls can be stored at 2~8°C after opening the bottle and can be stable for 30 days.
本试剂盒（含校准品和质控品）在2～8℃避光贮存，禁止冷冻，有效期为18个月。试剂开封后在机4～15℃避光保存，可稳定30天。校准品和质控品开瓶后2～8℃避光保存，可稳定30天。