Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 京械注准20242220121
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 京械注准20242220121 and owned by Beijing Savant Biotechnology Co., Ltd.. The device was approved on March 15, 2024.
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.
The indirect chemiluminescence method based on luminescent substrate and alkaline phosphatase, together with supporting detection reagents, is used in clinical practice for qualitative or quantitative detection of analytes in serum, plasma, whole blood and urine samples from human beings, including vitamins, amino acids and blood drug concentrations, hormones, myocardial diseases, infectious diseases, autoantibodies, tumor-related antigens, proteins and peptides, kidney diseases and liver diseases, immune function assays, allergen-related items, coagulation tests and other enzyme assays.
采用基于发光底物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、全血、尿液样本中的被分析物进行定性或者定量检测，包括维生素、氨基酸与血药浓度，激素，心肌疾病，感染性疾病，自身抗体，肿瘤相关抗原，蛋白质及多肽类，肾脏疾病和肝病项目，免疫功能测定，变应原相关项目，出凝血检查和其他酶类测定。
The automatic chemiluminescence immunoassay analyzer consists of a sampling system module, an orbital module, a sample filling module, a reagent tray module, a reagent filling module, a reaction cup feeding module, a reaction cup gripper module, an incubation block module, a magnetic separation module, an optical measurement module, a substrate module, a touch screen and an automatic chemiluminescence immunoassay analyzer software (release version: 1).
全自动化学发光免疫分析仪由进样系统模块、轨道模块、样本加样模块、试剂盘模块、试剂加样模块、反应杯上料模块、反应杯抓手模块、孵育块模块、磁分离模块、测光模块、底物模块、触控屏和全自动化学发光免疫分析仪软件（发布版本：1）组成。