Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 鲁械注准20242220793
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20242220793 and owned by Weihai Weigao BIOTECHNOLOGY Co., Ltd.. The device was approved on August 14, 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.
The automatic chemiluminescence immunoassay analyzer adopts the direct chemiluminescence method based on isoluminol or acridine ester, which is used together with supporting detection reagents, and is used in clinical practice for the qualitative or quantitative detection of analytes in serum, plasma and urine samples derived from the human body, 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, and other enzyme determinations.
全自动化学发光免疫分析仪采用基于异鲁米诺或吖啶酯的直接化学发光法，与配套的检测试剂共同使用，在临床上用于对来源于人体的血清、血浆、尿液样本中的被分析物进行定性或定量检测，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、其他酶类测定的临床检验项目。
The automatic chemiluminescence immunoassay analyzer is mainly composed of an analysis module, a sample management system (optional), a control system, accessories and consumables. The analysis module is composed of sample, reagent dispensing unit, reaction cup/disposable tip loading unit, reagent management unit, cleaning magnetic separation unit, measuring unit, reaction cup buffer, transport unit, incubation unit, liquid system, circuit control system, sample transfer module (optional); The sample management system consists of a sample management module and a sample distribution module. The control system consists of control software; Accessories and consumables include disposable reaction vessels, disposable tips, and waste bins. The analysis module can realize multiple parallel machines.
全自动化学发光免疫分析仪主要由分析模块、样本管理系统（选配）、操控系统、附件及耗材组成。分析模块由样本、试剂分注单元，反应杯/一次性吸头装载单元，试剂管理单元，清洗磁分离单元，测量单元，反应杯缓存、转运单元，孵育单元，液路系统，电路控制系统、样本传输模块（选配）组成；样本管理系统由样本管理模块、样本分配模块组成；操控系统由操控软件组成；附件及耗材包含一次性反应杯、一次性吸头和废料箱。分析模块可实现多台并机。