Gentamicin Assay Kit (Chemiluminescence Immunoassay) - NMPA Registration 京械注准20232400531
Access comprehensive regulatory information for Gentamicin Assay Kit (Chemiluminescence Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232400531 and owned by Beijing Diagreat Biotechnologies Co., Ltd.. The device was approved on September 01, 2023.
This page provides complete registration details including registrant information, province location (Beijing), 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.
It is used for in vitro quantitative determination of gentamicin content in human serum and plasma.
用于体外定量测定人血清、血浆中的庆大霉素含量。
name Composition Loading Reagent M Coated mouse anti-gentamicin monoclonal antibody superparamagnetic particles, > 0.1 g/L Proclin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Gentamicin-alkaline phosphatase marker, > 0.1 mg/L Proclin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Tris buffer, 50 mmol/L Proclin 300,0.1% Serves 50: 8mL; Serves 100: 15mL Calibrators (Optional) 3 levels, lyophilized product, containing gentamicin, stabilizer, preservative Target Concentration Range: S1:0-3micro; g/mL;S2:3-6micro; g/mL;S3:6-14micro; g/mL Reconstitute 1 mL volume Calibration information A QR code containing information about the main calibration curve / Note: Calibrator assignment is batch-specific, and the target value of each lot is detailed in the label.
名称 组成成分 装量 试剂M 包被鼠抗庆大霉素单克隆抗体超顺磁性微粒，＞0.1 g/L Proclin 300，0.1% 50人份：3mL； 100人份：6mL 试剂1 庆大霉素-碱性磷酸酶标记物，＞0.1mg/L Proclin 300，0.1% 50人份：3mL； 100人份：6mL 试剂2 Tris缓冲液，50mmol/L Proclin 300，0.1% 50人份：8mL； 100人份：15mL 校准品 （选配） 3水平，冻干品，含庆大霉素，稳定剂，防腐剂 目标浓度范围： S1：0-3micro;g/mL；S2：3-6micro;g/mL；S3：6-14micro;g/mL 复溶体积1mL 校准信息 二维码，包含主校准曲线信息 / 注：校准品赋值具有批特异性，每批次靶值详见标签。
The reagents are stored at 2 °C ~ 8 °C
试剂在2℃～8℃条件下存放有