Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 鲁械注准20242220894
Access comprehensive regulatory information for Fully automatic chemiluminescence immunoassay analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242220894 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on September 30, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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.
This product uses acridine ester-based direct chemiluminescence method for qualitative and/or quantitative analysis of analytes in serum and plasma samples derived from human beings, including hormones, myocardial diseases, infectious diseases, tumor-related antigens, proteins and peptides, experimental diagnosis of liver diseases, determination of vitamins, amino acids and blood concentrations, immune function determination, other enzyme determinations and other clinical test items.
本产品采用基于吖啶酯的直接化学发光法，在临床上用于对来源于人体的血清及血浆样本中的被分析物进行定性和/或定量分析，包括激素、心肌疾病、感染性疾病、肿瘤相关抗原、蛋白质及多肽类检验、肝病的实验诊断、维生素、氨基酸与血药浓度测定、免疫功能测定、其他酶类测定等临床检验项目。
The automatic chemiluminescence immunoassay analyzer consists of two parts: the host and the software components. The main engine is the running reaction determination part of the analyzer, which is mainly composed of an analysis module and an optional module, and the analysis module includes a reagent processing system, a reaction cup automatic loading system, a reaction cup transfer system, a reagent sample dispensing system, a reaction solution mixing system, a cleaning magnetic separation system, a substrate system, a photometric and reaction system. Optional modules include a handheld barcode scanning system, sample preparation module, rear track module, 3-axis display operator station, concentrated cleaning fluid tank, dilution cleaning solution tank, analyzer wash tank, waste liquid tank and waste level sensor.
全自动化学发光免疫分析仪由主机和软件组件两部分组成。其中主机为分析仪的运行反应测定部分，主要由分析模块和选配模块组成，分析模块包含试剂处理系统、反应杯自动装载系统、反应杯转运系统、试剂样本分注系统、反应液混匀系统、清洗磁分离系统、底物系统、光测及反应系统。选配模块包括手持条码扫描系统、样本前处理模块、后侧轨道模块、三轴显示器操作台、浓缩清洗液桶、稀释清洗液桶、分析仪洗液桶、废液桶及废液液位传感器。