Advertisement

Picture EBD Group Cell & Gene Exchange 2017 Washington DC USA May 600x60px
Document › Details

Thermo Fisher Scientific Inc.. (6/16/14). "Press Release: Thermo Fisher Scientific Registers San Jose Facility with FDA". Baltimore, MD.

Region Region Baltimore, MD
  Country United States (USA)
Organisations Organisation Thermo Fisher Scientific Inc., San Jose
  Group Thermo Fisher (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product mass spectrometer
  Product 2 diagnostic device, in vitro
Persons 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.

###

Contact:

Stu Matlow
San Jose, Calif., USA
Phone: +1 408-965-6408
stu.matlow@thermofisher.com

   
Record changed: 2016-03-20

Advertisement

Picture EBD Group Cell & Gene Exchange 2017 Washington DC USA May 600x60px

More documents for Thermo Fisher (Group)


To subscribe to our free, monthly mass spectrometry newsletter, please send an e-mail to info@iito.de and simply fill the subject line with the word »MSC newsletter«

To get even more information, please take a look at our [gs] professional services offering and read the gene-sensor Product Flyer [PDF file]

Please visit also our web portals for the Eurpean life sciences and the life sciences in German-speaking Europe (DE, AT & CH) at Life-Sciences-Germany.com and Life-Sciences-Europe.com

Advertisement

Picture Fairtec GmbH Worldwide Event Solutions 600x60px




» top

Advertisements

Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px Picture EBD Group Cell & Gene Exchange 2017 Washington DC USA May 120x180px Picture [LSE] Life-Sciences-Europe.com – The Business Web Portal 120x600px Banner Fairtec GmbH Solutions for Smarter Business Events Exhibitions 120x120px Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px