Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 京械注准20242220001
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20242220001 and owned by Beijing Savant Biotechnology Co., Ltd.. The device was approved on January 04, 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 substrates and enzymes, together with supporting detection reagents, is used in clinical practice for the qualitative or quantitative detection of analytes in serum and plasma samples derived from human beings, including hormones, diabetes, myocardial markers, tumor markers, and infectious diseases.
采用基于发光底物和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，包括激素、糖尿病、心肌标志物、肿瘤标志物、感染性疾病的相关项目。
The automatic chemiluminescence immunoassay analyzer consists of a sample processing module, a reagent processing module, a reaction cup transfer module, a sample reagent filling module, a reaction solution mixing module, an incubation module, a sample loading gripper module, a cleaning gripper module, a cleaning module, a detection module, a substrate module, a touch screen, a power cord and SAVANT series of automatic chemiluminescence immunoassay analyzer software (release version: 1).
全自动化学发光免疫分析仪由样本处理模块、试剂处理模块、反应杯转运模块、样本试剂加注模块、反应液混匀模块、孵育模块、加样夹爪模块、清洗夹爪模块、清洗模块、检测模块、底物模块、触控屏、电源线和SAVANT 系列全自动化学发光免疫分析仪软件（发布版本：1）组成。