Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 桂械注准20242220373
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 桂械注准20242220373 and owned by URIT MEDICAL Electronic Co., Ltd.. The device was approved on January 14, 2025.
This page provides complete registration details including registrant information, province location (Guangxi), 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.
该产品采用基于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、血浆和尿液样本中的被分析物进行定性或定量检测,包括激素、糖尿病、心肌标志物、肿瘤标志物、感染性疾病等相关项目,其检测结果作为临床诊断的参考依据,最终的诊断结果需由医生确定.
该产品采用基于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、血浆和尿液样本中的被分析物进行定性或定量检测，包括激素、糖尿病、心肌标志物、肿瘤标志物、感染性疾病等相关项目，其检测结果作为临床诊断的参考依据，最终的诊断结果需由医生确定。
It consists of an analysis module, an operation department, accessories and consumables. The analysis module comprises a sample processing module, a reagent processing module, a reaction cup transfer module, a sample reagent dispensing module, a reaction solution mixing module, a reaction module and a substrate solution module; The operation department includes industrial computer, touch screen, automatic chemiluminescence immunoassay analyzer software; Accessories and consumables include disposable reactor cups and solid waste bins.
由分析模块、操作部、附件及耗材组成。其中分析模块包括样本处理模块、试剂处理模块、反应杯转运模块、样本试剂分注模块、反应液混匀模块、反应模块和底物液模块；操作部包括工控机、触控屏、全自动化学发光免疫分析仪软件；附件及耗材包括一次性反应杯和固体废物桶。