Ferritin assay kit (chemiluminescence immunoassay) - NMPA Registration 京械注准20232400532
Access comprehensive regulatory information for Ferritin 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20232400532 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 the quantitative determination of ferritin content in human serum or plasma in vitro.
用于体外定量测定人血清或血浆中铁蛋白的含量。
name Composition Loading Reagent M Superparamagnetic particles coated with ferritin antibodies, > 0.1 g/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Anti-ferritin antibody-alkaline phosphatase marker, > 0.1 mg/L Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Sample processing fluid Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 5mL; Serves 100: 10mL Calibrators (Optional) 3 levels, ferritin, stabilizers, preservatives Target Concentration Range: Level 1: 0-10 ng/mL, Level 2: 10-500 ng/mL, Level 3: 500-1500 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 包被着铁蛋白抗体的超顺磁性微粒，＞0.1g/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂1 抗铁蛋白抗体-碱性磷酸酶标记物，＞0.1mg/L Tris缓冲液，50 mmol/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂2 样本处理液 Tris缓冲液，50mmol/L ProClin 300，0.1% 50人份：5mL； 100人份：10mL 校准品 （选配） 3水平，含铁蛋白，稳定剂，防腐剂 目标浓度范围： 水平1：0-10 ng/mL；水平2：10-500 ng/mL；水平3：500-1500 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