Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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.


Scientific News
Detecting Alzheimer's with Smell Test
Odour identification test may offer low-cost alternative for predicting cognitive decline and detecting early-stage Alzheimer’s disease.
CDC Updates Zika Recommendations
CDC has issued updated Zika recommendations and guidance for healthcare providers with a focus on sexual transmission.
Review of the Analysis of Haemoglobin A1c for Diabetes Diagnostics
This paper aims to clarify methods, units, quality requirements, reference and cutoff limits for hemoglobin A1c (HbA1c) and ratio of blood glucose/HbA1c on the basis of the results from Finnish quality control surveys by comparing them to the literature.
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Drug - Gene 'One-Two' Punch Against Cancer
Researchers identify gene-drug combinations that, together, target and kill cancer cells while not targeting healthy cells.
Liquid Biopsies Treating Ovarian Cancer
Researchers have discovered a promising monitor and treat recurrence of ovarian cancer. Detecting cancer long before tumours reappear.
72% Rise in Metastatic Prostate Cancer
Over the 2003-2013 period metastatic cancer has increased by an average of 72%, this could be caused by lax screening, more aggressive disease or both.
Lab-Tested Diagnosis Needed When Treating Persistent Diarrhea
New PCR multiplex method makes lab testing more effective.
Biomarker for Multiple Sclerosis Detection Discovered
Winthrop-University Hospital researchers discover biomarker for multiple sclerosis detection.
Scientists Link Bipolar Disorder to Unexpected Brain Region
Researchers from The Scripps Research Institute have found that gene within the brain’s striatum could be linked to biopolar disorder.
SELECTBIO

SELECTBIO Market Reports
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!