China NMPA legacy archive 国械注准20243220377Fully automated nucleic acid amplification analyzer
- Device class
- Class III
- Model specifications
- GN 7000、GN 7060、GN 7080、GN 7120
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243220377
- Approval date
- February 21, 2024
- Expiry date
- February 20, 2029
- Province/Region
- Jiangsu
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
- Production address
- 南京市六合区沿江工业开发区博富路9号，南京市江北新区科丰路6号
The product is based on the principle of real-time fluorescent polymerase chain reaction and is used in conjunction with supporting detection reagents for the extraction and qualitative detection of analytes derived from swab samples, including pathogen items.
该产品基于实时荧光聚合酶链式反应原理，与配套的检测试剂共同使用，在临床上用于对来源于拭子样本中的被分析物进行提取及定性检测，包括病原体项目。
The automatic nucleic acid amplification analyzer is composed of a heating system, an optical path system, a detection system, a main control display system, a printer system, a power supply system, and random software (release version V1.0).
全自动核酸扩增分析仪由加热系统，光路系统，检测系统，主控显示系统，打印机系统，电源系统，随机软件（发布版本V1.0）组成。
- Appendix
- 产品技术要求
This static archive preserves historical registration fields and translations for Fully automated nucleic acid amplification analyzer, registration 国械注准20243220377. It does not establish current authorization or complete current product details.
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