Serum Amyloid A Assay Kit (Chemiluminescence Immunoassay) - NMPA Registration 京械注准20232400534
Access comprehensive regulatory information for Serum Amyloid A 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20232400534 and owned by Beijing Diagreat Biotechnologies Co., Ltd.. The device was approved on September 01, 2023.
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It is used for the quantitative determination of serum amyloid A content in human serum and plasma in vitro.
用于体外定量测定人血清、血浆中血清淀粉样蛋白A的含量。
name Composition Loading Reagent M Superparamagnetic particles coated with anti-serum amyloid A antibody, > 0.1 g/L ProClin300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Anti-serum amyloid A antibody-alkaline phosphatase marker, > 0.1 mg/L ProClin300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Tris buffer, 50 mmol/L ProClin300,0.1% Serves 50: 8mL; Serves 100: 15mL Calibrators (Optional) 3 levels, lyophilized, containing serum amyloid A, stabilizers, preservatives Target Concentration Range: S1:0-5mu; g/mL;S2:10-100mu; g/mL;S3:100-300mu; 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 包被着抗血清淀粉样蛋白A抗体的超顺磁性微粒，＞0.1 g/L ProClin300，0.1% 50人份：3mL； 100人份：6mL 试剂1 抗血清淀粉样蛋白A抗体-碱性磷酸酶标记物，＞0.1mg/L ProClin300，0.1% 50人份：3mL； 100人份：6mL 试剂2 Tris缓冲液，50mmol/L ProClin300，0.1% 50人份：8mL； 100人份：15mL 校准品 （选配） 3水平，冻干品，含血清淀粉样蛋白A， 稳定剂，防腐剂 目标浓度范围： S1：0-5mu;g/mL；S2：10-100mu;g/mL；S3：100-300mu;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