Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

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
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 2,800+ scientific posters on ePosters
  • More Than 4,000+ 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 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 UK Appoints Product Specialist for AA
Company strengthens focus on molecular and atomic spectroscopy with new specialist recruit.
Thursday, July 19, 2012
Shimadzu and The University of Texas Form Shimadzu Center for Advanced Analytical Chemistry
Located in the university’s Chemistry & Physics Building, the center contains $6 million of chromatography, mass spectrometry and spectroscopy equipment, which is the largest installation of Shimadzu analytical instrumentation in the Western Hemisphere.
Tuesday, April 10, 2012
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
Spectroscopy Veteran Joins Shimadzu UK to Drive UK Sales Forward
Dr Robert Keighley has appointed as new spectroscopy and TOC business manager.
Friday, September 16, 2011
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
Multivariate Data Analysis Solutions for FTIR Spectrophotometry
Shimadzu Scientific Instruments and CAMO Software have announced a partnership that will enable Shimadzu to expand its capabilities for FTIR spectrophotometry. Shimadzu will now provide CAMO Software’s multivariate data analysis (MVDA) software, The Unscrambler® to FTIR customers requiring chemometric analysis.
Friday, November 05, 2010
Shimadzu, Ceres Nanosciences and Nonlinear Dynamics Introduce Nanotrap™ Biomarker Discovery Platform
Shimadzu Scientific Instruments has partnered with Ceres Nanosciences and Nonlinear Dynamics to bring the future of biomarker discovery to laboratory researchers.
Tuesday, March 16, 2010
Shimadzu and Phenomenome Discoveries Announce Exclusive Collaboration
Shimadzu and PDI will develop software tools for global profiling using high mass accuracy MSn data.
Monday, July 02, 2007
Scientific News
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.
The MaxSignal Colistin ELISA Test Kit from Bioo Scientific
Kit can help prevent the antibiotic apocalypse by keeping last resort drugs out of the food supply.
"Good" Mozzie Virus Might Hold Key to Fighting Human Disease
Australian scientists have discovered a new virus carried by one of the country’s most common pest mosquitoes.
Non-Disease Proteins Kill Brain Cells
Scientists at the forefront of cutting-edge research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s have shown that the mere presence of protein aggregates may be as important as their form and identity in inducing cell death in brain tissue.
Closing the Loop on an HIV Escape Mechanism
Research team finds that protein motions regulate virus infectivity.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Potential Treatment for Life-Threatening Viral Infections Revealed
The findings point to new therapies for Dengue, West Nile and Ebola.
World’s First Therapeutic Venom Database
Open-source library describes nearly 43,000 effects on the human body.
Biologists Induce Flatworms to Grow Heads and Brains of Other Species
Findings shed light on role of a new kind of epigenetic signaling in evolution, could yield clues for understanding birth defects and regeneration.
Fat Cells Originating from Bone Marrow Found in Humans
Cells could contribute to diabetes, heart disease.
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos