Document › Details
Thermo Fisher Scientific Inc.. (6/16/14). "Press Release: Thermo Fisher Scientific Registers San Jose Facility with FDA". Baltimore, MD.
|Country||United States (USA)|
|Organisation||Thermo Fisher Scientific Inc., San Jose|
|Group||Thermo Fisher (Group)|
|Organisation 2||FDA (US Food and Drug Administration)|
|Group||United States (govt)|
|Product 2||diagnostic device, in vitro|
|Person||Shine, Dan (Thermo Fisher 201304 President of Chromatography + Mass Spectrometry Business)|
|Person 2||Matlow, Stuart (Stu) (Thermo Fisher 201206 Public Relations Manager Chromatography + Mass Spectrometry before Agilent)|
Thermo Fisher Scientific today announced that its San Jose, California facility has registered with the U.S. Food and Drug Administration (FDA) as a medical device establishment. The site has established a quality system in accordance with the FDA Quality System Regulations to design and manufacture devices for analyzing samples from patients for in vitro diagnostic use.
"Last year we achieved ISO 13485 certification for the San Jose site, and this FDA registration is the next major milestone in our ongoing initiative to develop Class 1 mass spectrometry-based instruments for the clinical market," said Dan Shine, president, chromatography and mass spectrometry, Thermo Fisher Scientific.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our four premier brands - Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
San Jose, Calif., USA
Phone: +1 408-965-6408
Record changed: 2016-03-20
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