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Sciex Mass Spec System Approved by CFDA


Sciex said today that its AB Sciex Triple Quad 4500MD LC-MS/MS system has been approved by the China Food and Drug Administration for use as a medical device.

With the approval, the system, which consists of the LC-MS/MS instrumentation along with Sciex’s Analyst MD, Cliquid MD, and MultiQuant MD software, can be used in China for in vitro diagnostic testing.

“We know that the routine diagnostic testing lab requires accurate trace level quantitation of multiple compounds in human specimens,” Shao Hong, SCIEX China GM said in a statement, adding that the company believes the instrument will help clinical labs “by saving time, cutting costs, and supporting physicians with greater confidence and reliable results.”

China Med Device, LLC, specializing in providing turn-key solutions for medtech companies entry into China. We are your partner in CFDA registration and your product’s commercialization in China. If you have any feedback on this post or would like to know more of our services, please email us at or visit us at

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