Chemiluminescence analyzer - NMPA Registration 粤械注准20182220442
Access comprehensive regulatory information for Chemiluminescence 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 粤械注准20182220442 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on October 17, 2022.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
Indirect chemiluminescence method based on AMPPD and alkaline phosphatase, used together with supporting detection reagents, is used in clinical practice for qualitative or quantitative detection of analytes in serum and plasma samples derived from human body, including allergen-related item determination, hormone determination, autoantibody detection, tumor-related antigen determination, infectious disease experimental detection, protein and peptide testing, experimental diagnosis of liver disease, immune function measurement, vitamin determination, experimental diagnosis of myocardial diseases and D-dimer item determination.
基于AMPPD和碱性磷酸酶的间接化学发光法，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、血浆样本中的被分析物进行定性或者定量检测，包括变应原相关项目测定、激素测定、自身抗体检测、肿瘤相关抗原测定、感染性疾病实验检测、蛋白质及多肽类检验、肝病的实验诊断、免疫功能测定、维生素测定、心肌疾病的实验诊断和D-二聚体项目测定。
It is mainly composed of analysis department (host), operation department and output department. The analysis department (host) is mainly composed of sampling system, incubation system, reaction vessel loading and conveying system, reaction cup automatic cleaning system, optical detection system, liquid path system and control system; The operation department is mainly composed of touch integrated computer and software components; The output section is mainly composed of a printer (optional).
主要由分析部（主机）、操作部和输出部组成。分析部（主机）主要由采样系统、孵育系统、反应杯装载传送系统、反应杯自动清洗系统、光学检测系统、液路系统和控制系统组成；操作部主要由触控一体电脑以及软件组件组成；输出部主要由打印机（选配）组成。
08-APR-28