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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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
‘Smelling’ Prostate Cancer
A research team from the University of Liverpool and the University of the West of England (UWE Bristol) has reached an important milestone towards creating a urine diagnostic test for prostate cancer that could mean that invasive diagnostic procedures that men currently undergo eventually become a thing of the past.
Charting Kidney Cancer Metabolism
Changes in cell metabolism are increasingly recognized as an important way tumors develop and progress, yet these changes are hard to measure and interpret. A new tool designed by MSK scientists allows users to identify metabolic changes in kidney cancer tumors that may one day be targets for therapy.
Portable Kit Can Recover Traces of Chemical Evidence
A chemist at the National Institute of Standards and Technology (NIST) has developed a portable version of his method for recovering trace chemicals such as environmental pollutants and forensic evidence including secret graves and arson fire debris.
Diagnosis of Two Rare Childhood Diseases Improved
For the first time, researchers have developed tests that could improve the diagnosis of two rare childhood diseases known as congenital disorders of glycosylation (CDGs) and metachromatic leukodystrophy, and that could even lead to new treatments for CDGs.
Artemisinin Mechanism Uncovered
New understanding of how artemisinin works could facilitate development of new drugs and therapeutic strategies against malaria.
Cleaning Out the Membrane Each Day
Cell membranes are made up of a lipid bilayer that is constantly changing due to the flux of material in and out of the cell.
AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Novel Approach to Understanding Brain Function
Russell Poldrack scanned his brain to create the most detailed map of brain connectivity ever.
New Analysis Technique for Chiral Activity in Molecules
Professor Hyunwoo Kim of the Chemistry Department and his research team have developed a technique that can easily analyze the optical activity of charged compounds by using nuclear magnetic resonance (NMR) spectroscopy.
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!