Folate Assay Kit (Chemiluminescence Immunoassay) - NMPA Registration 京械注准20232400535
Access comprehensive regulatory information for Folate 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20232400535 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 folic acid content in human serum or plasma.
用于体外定量测定人体血清或血浆中叶酸的含量。
name Composition Loading Reagent M Superparamagnetic particles coated with antibiotin antibody, > 0.1 g/L Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Folate-alkaline phosphatase marker, > 0.1 mg/L MES buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Biotinylated folate-binding proteins MES buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Sample processing solution A Protein lysates Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 3mL Sample Processing Solution B 0.5 M sodium hydroxide solution Serves 50: 3mL; Serves 100: 3mL Calibrators (Optional) 3 levels, containing folic acid, stabilizers, preservatives Target Concentration Range: Level 1: 0-2 ng/mL, Level 2: 2-10 ng/mL, Level 3: 10-30 ng/mL 1mL 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 包被着抗生物素抗体的超顺磁性微粒，＞0.1g/L Tris缓冲液，50mmol/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂1 叶酸-碱性磷酸酶标记物，＞0.1mg/L MES缓冲液，50 mmol/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂2 生物素化叶酸结合蛋白 MES缓冲液，50mmol/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 样本处理液A 蛋白裂解剂 Tris缓冲液，50mmol/L ProClin 300，0.1% 50人份：3mL； 100人份：3mL 样本处理液B 0.5M的氢氧化钠溶液 50人份：3mL； 100人份：3mL 校准品 （选配） 3水平，含叶酸，稳定剂，防腐剂 目标浓度范围： 水平1：0-2 ng/mL；水平2：2-10 ng/mL；水平3：10-30 ng/mL 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