China NMPA legacy archive 国械注准20253220297全自动核酸提纯及实时荧光 PCR 分析系统
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Class IIINMPAApproved January 26, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- MN1440、MN1440s、MN2880、MN2880Pro
- Approval department
- State Drug Administration
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253220297
- Approval date
- January 26, 2025
- Expiry date
- January 25, 2030
Registrant
- Province/Region
- Guangdong
- Address
- Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen
广东
深圳市南山区高新技术产业园区科技南十二路迈瑞大厦1-4层
Production facility
- Production address
- 深圳市光明新区南环大道1203号
Intended use
English
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。
Structure and composition
English
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。
Additional information
- Appendix
- 产品技术要求
About this record
This static archive preserves historical registration fields and translations for 全自动核酸提纯及实时荧光 PCR 分析系统, registration 国械注准20253220297. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.