赛默飞世尔科技液质联用系统获体外诊断设备CE标志

  近日，赛默飞世尔科技 (Thermo Fisher Scientific)表示，他们的Prelude MD HPLC、Endura MD质谱分析仪及ClinQuan MD软件已经获得了体外诊断设备（IVDD）的CE标志。
  获得CE标志的认可或将使这些设备在欧洲用来进行一般的体外诊断，而且这些设备也可以组成全套的液相色谱-质谱联用仪系统（LC-MS系统）。
  赛默飞世尔临床市场的战略负责人在一项声明中表示，我们坚定不移地致力于将LC-MS的优势带到临床市场中，而这三类产品也将是推广使得质谱技术更加有用的一部分应用，并且可以促进临床医生便于使用。
  早在去年，赛默飞世尔就已经已经向FDA提交了一款相同模式的设备的申请，来作为I类设备，从而使其可以在美国更加便于临床使用。（转化医学网360zhyx.com）
  以上为转化医学网原创翻译整理，转载请注明出处和链接！
转化医学网推荐的新闻阅读：

Thermo Fisher Receives IVDD CE Mark for LC-MS System
Thermo Fisher Scientific said today that it has received the in vitro diagnostics device (IVDD) CE mark for its Thermo Scientific Prelude MD HPLC, Endura MD mass spectrometer, and ClinQuan MD software.

The approval makes these instruments, which constitute a full LC-MS system, available for general in vitro diagnostic use inEurope.

"We're strongly committed to bringing the advantages of LC-MS to the clinical market," Bradley Hart, strategic director, life sciences mass spectrometry, clinical markets, for Thermo Fisher, said in a statement. "These three products are part of a larger initiative to make mass spectrometry more useful and accessible to clinicians."

The move follows the company's announcement last year that it registered the same set of devices with the US Food and Drug Administration as Class I devices, making them available for clinical use in the US.