China NMPA legacy archive 渝械注准20242220413Time-of-Flight Mass Spectrometry System
- Device class
- Class II
- Model specifications
- EXS 8000
- Approval department
- Chongqing Municipal Drug Administration
- Registration number
- 渝械注准20242220413
- Approval date
- October 17, 2024
- Expiry date
- October 16, 2029
- Province/Region
- Chongqing
- Address
- Floor 1-4, Building 30, No. 6 Taikang Road, Area C, Jianqiao Industrial Park, Dadukou District, Chongqing
- Production address
- 重庆市大渡口区建桥工业园C区太康路6号30栋第1-4层、5层A区；重庆市大渡口跳磴镇海兴路333号建桥生物医药园附3号第1-5层、附4号第1-5层；重庆市大渡口区建桥工业园C区太康路3号24-25栋2层A区
The product is based on matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) technology, which can analyze nucleic acid samples from human bodies by detecting the molecular weight of known nucleic acid fragments.
产品基于基质辅助激光解吸电离飞行时间质谱（MALDI-TOF MS）技术，通过检测已知核酸片段分子量，可对来源于人体的核酸样本进行分析。
It is mainly composed of a host, software and a target holder. The main machine is composed of an ion detector, a vacuum system, a mass analyzer, an ion source, a laser, an XY mobile platform, a target camera and a high-voltage pulse box power supply system. The software includes time-of-flight mass spectrometry system acquisition software (release version: V1) and time-of-flight mass spectrometry system gene analysis software (release version: V1), and the software is a control software component.
主要由主机、软件及靶托组成。其中主机由离子探测器、真空系统、质量分析器、离子源、激光器、XY移动平台、靶点摄像以及高压脉冲盒电源系统组成；其中软件包括飞行时间质谱系统采集软件（发布版本：V1）和飞行时间质谱系统基因分析软件（发布版本：V1），软件为控制型软件组件。
- Remark
- 首次注册。
This static archive preserves historical registration fields and translations for Time-of-Flight Mass Spectrometry System, registration 渝械注准20242220413. It does not establish current authorization or complete current product details.
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