全自动核酸提纯及实时荧光 PCR 分析系统 - NMPA Registration 国械注准20253220297
Access comprehensive regulatory information for 全自动核酸提纯及实时荧光 PCR 分析系统 in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253220297 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was approved on January 26, 2025.
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.
本产品基于聚合酶链式反应原理(PCR)和实时荧光监测技术，自动完成核酸提取纯化（磁珠法）、扩增及检测的操作步骤，与配套的检测试剂共同使用，在临床上用于对来源于人体样本中的靶核酸（DNA/RNA）进行定性和定量检测，包括病原体项目。
该产品由耗材管理模块、试剂管理模块、试剂分注模块、样本管理模块、样本分注模块、耗材传动模块、核酸提取模块、 PCR 扩增模块、废弃物管理模块、污染控制模块、电气控制系统、电源部件和软件（发布版本01）组成。