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Thermo Fisher Scientific Registers San Jose Facility with FDA
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 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.
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