Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Thermo Registers San Jose Facility with FDA

Published: Monday, June 16, 2014
Last Updated: Monday, June 16, 2014
Bookmark and Share
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.

Thermo Fisher Scientific announced that its San Jose, California facility has registered with the U.S. Food and Drug Administration (FDA) as a medical device establishment. 

“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.



Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More Than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Thermo Launches Geneticon
Thermo Fisher Scientific launches GenetiCon, a virtual resource showcasing the real-life science behind superheroic powers and more.
Tuesday, July 07, 2015
Thermo Fisher Agrees to Buy Alfa Aesar for $403M
The company announced a definitive agreement to buy the research chemical manufacturer for $403 million.
Friday, June 26, 2015
Ebola Sequencing Data Released to Global Research Community Online
To curb further spread of Ebola in Sierra Leone, a team of scientists that is part of an international, multi-organizational effort has released their first dataset of the virus’ genetic structure online.
Wednesday, June 03, 2015
Thermo's NGS Platform Selected for Nationwide Clinical Research Program
National Cancer Institute-MATCH trial to sequence thousands of tumor samples using Ion Torrent targeted sequencing technology.
Monday, June 01, 2015
Thermo Strengthens Bioprocessing Offering with Advanced Scientifics Acquisition
Thermo Fisher Scientific has acquired Advanced Scientifics, Inc., a global provider of single-use technologies for customized bioprocessing solutions, for $300 million in cash.
Friday, February 06, 2015
Thermo Fisher Q3 Revenues up 31 Percent
Thermo Fisher announced that revenues grew 31% to $4.17 billion for the third quarter ended September 27, 2014.
Thursday, October 23, 2014
Thermo Scientific Announces Listing of the Ion PGM Dx System
Company has completed the listing with the U.S. FDA as class II medical device.
Saturday, September 20, 2014
Thermo Fisher, NRLs Team to Confirm Dioxins in Feed and Food
Thermo Fisher Scientific worked closely with national reference labs (NRLs) in the European Union to support the development of new regulation.
Monday, September 08, 2014
Thermo Completes Sale of Cole-Parmer to GTCR
Thermo Fisher Scientific Inc. announced that it has completed the sale of its Cole-Parmer customer channel business to private equity firm GTCR LLC for approximately $480 million in cash.
Wednesday, August 20, 2014
Thermo Supports Distinguished Analytical Chemistry Seminar Series at NC State
An endowment established by the company provides opportunities to attend presentations by leading analytical chemistry authorities.
Tuesday, August 19, 2014
NSF International Expands Use of Thermo Scientific Watson LIMS
NSF International implements Thermo Scientific Watson LIMS to support bioanalytical testing for both clinical and non-clinical research studies at Bristol, CT laboratory.
Saturday, August 09, 2014
Thermo, NewLab Sign Forensic Sample Processing Distribution Agreement
Under the agreement, Thermo Fisher is the sole distributor and servicing agent of the CPA300™ and CPA200™ card processing instruments.
Friday, July 25, 2014
Thermo to Sell Cole-Parmer for $480M
Company has signed a definitive agreement to sell its Cole-Parmer channel business to private equity firm GTCR, LLC for $480 million in cash.
Monday, July 21, 2014
Reimagining UHPLC
To learn more about the new Vanquish UHPLC system from Thermo Fisher Scientific we spoke to Wulff Niedner, Director of HPLC Product Marketing.
Thursday, July 17, 2014
ATCC, CDC and Thermo Partner on Public Health RT-PCR Assay
New technology supports HIV-1 drug resistance surveillance in resource-limited countries.
Wednesday, June 25, 2014
Scientific News
Health Risks of Saturated Fats Aggravated by Immune Response
Research shows that the presence of saturated fats resulted in monocytes migrating into the tissues of vital organs.
Changing the Biological Data Visualisation World
Scientists at TGAC, alongside European partners, have created a cutting-edge, open source community for the life sciences.
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
Low-level Arsenic Exposure Before Birth Associated with Early Puberty in Female Mice
Study examine whether low-dose arsenic exposure could have similar health outcomes in humans.
Inciting an Immune Attack On Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Intensity of Desert Storms May Affect Ocean Phytoplankton
MIT study finds phytoplankton are extremely sensitive to changing levels of desert dust.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!