Corporate Banner
Satellite Banner
Chromatography
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Shimadzu Registers HPLC and LCMS Instruments as Class I Medical Devices with FDA

Published: Tuesday, April 01, 2014
Last Updated: Wednesday, April 09, 2014
Bookmark and Share
Products are the first Shimadzu analytical instruments registered with the FDA as medical devices.

In response to a growing need for analytical measurement in healthcare applications, Shimadzu Corporation, Japan, has registered several of the company’s high-performance liquid chromatographs (HPLC) and high-performance liquid chromatograph mass spectrometers (LCMS) as Class I medical devices with the Food and Drug Administration. 

The use of analytical devices in medical screenings and disease prevention has been on the rise in recent years. Starting in July 2011, the FDA required manufacturers to register analytical instruments as Class I medical devices to ensure their accuracy and reliability when used in healthcare applications.

The following Shimadzu instruments have been registered as Class I medical devices:

LC-20 CL and LC-30 CL HPLCs

Single-quad LCMS-2020 CL

Triple-quad LCMS-8030 CL, LCMS-8040 CL and LCMS-8050 CL

The registered instruments were designed in Shimadzu Corporation’s head office (Sanjo Works, Japan) and manufactured at Shimadzu USA Manufacturing (SUM) located in Canby, Ore. Both facilities obtained ISO 13485 certification, the globally recognized international quality management standard for medical equipment, in 2013. SUM is conducting manufacturing of the medical devices mentioned under the FDA regulation 21 CFR 820.


Further Information

Join For Free

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 3,000+ scientific posters on ePosters
  • More than 4,500+ 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

Shimadzu Wins R&D 100 Award for Nexera Unified Chromatography System
The Nexera UC system is the world’s first ever unified and fully automated system that combines supercritical fluidic extraction (SFE) with supercritical fluid chromatography (SFC).
Tuesday, November 24, 2015
Agilent, Shimadzu Release GC Instrument Control for CDS
The instrument control provides customers more freedom of choice when selecting a chromatography data system.
Wednesday, August 27, 2014
Shimadzu, Indigo BioSystems Announce Partnership
The companies will leverage the power of ASCENT™ clinical solutions on ultra-fast mass spectrometry platforms.
Monday, June 16, 2014
Shimadzu Corporation, MacCoss Lab of Biological Mass Spectrometry, UW Collaborate
The companies will leverage the power of ASCENT™ clinical solutions on ultra-fast mass spectrometry platforms.
Monday, June 16, 2014
Shimadzu Establishes Latin American Subsidiary
Uruguayan subsidiary will strengthen company's sales and distribution whilst providing better support for customers and distributors in Central and South America.
Tuesday, November 12, 2013
Shimadzu Achieves ISO 13485 Certification for US LC-MS Facility
ISO 13485 is the globally recognized international quality management standard for medical equipment.
Wednesday, September 25, 2013
Shimadzu UK Grows Sales Orders by 30%!
Company has achieved sales order growth across many products in the Shimadzu range.
Tuesday, May 07, 2013
Shimadzu Corporation Names New Director and President of Shimadzu Scientific Instruments
Shuzo Maruyama has been named president of Shimadzu Scientific Instruments (SSI)
Monday, March 12, 2012
Shimadzu UK Opens Evaluation Laboratory Centre to Promote Excellence in Analytical Instrumentation
New 1500m² world-class product evaluation laboratory facility at UK headquarters in Buckinghamshire.
Wednesday, July 13, 2011
Scientific News
Why do Tomatoes Smell "Grassy"?
Researchers identify enzymes that convert the grassy smell of tomatoes into a sweeter scent.
Plasma Biomarkers for Breast Cancer Diagnosis
Plasma lipidomics profiling identified lipid biomarkers in distinguishing early-stage breast cancer from benign lesions.
A Mechanistic Tool for Studying Fungal Pathogens
This study presents an overview of lipid extraction, chromatographic separation and mass spectrometry employed in qualitative and quantitative sphingolipidomics in fungi.
Newborn Screening Test Developed For Rare, Deadly Neurological Disorder
Scientists have developed a new dried blood spot screening test for Niemann-Pick type C, with goal to speed diagnosis and treatment.
Grant to Fund Million Peaks Project
The European Research Council (ERC) has awarded a prestigious Advanced Grant to Prof. Peter Schoenmakers, Prof. Albert Polman and Prof. Huib Bakker, all three of whom work at the University of Amsterdam (UvA).
Altered Metabolism of Four Compounds Drives Glioblastoma Growth
Findings suggest new ways to treat the malignancy, slow its progression and reveal its extent more precisely.
Why Bearcats Smell Like Buttered Popcorn
Researchers pinpoint chemical compound that gives rare animal its popcorn-like scent.
Human Gut Microbiome Evolution
Westerners have a less-diverse gut microbiome compared to hunter-gatherers, but how and why these microbe collections diverged has largely remained a mystery.
Potential Diagnostic for Dengue Fever
Scientists from Colorado State University have explored the use of small molecules in patient serum for diagnosis of dengue fever and potentially predicting progression to the severe disease.
Non-Destructive Sensing of Fish Freshness
Is there any reliable way to know whether frozen fish is fresh or not?
SELECTBIO

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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!