Product category:
Other analytical instruments
News Release from: Waters
Edited by the Laboratorytalk Editorial
Team on 26 July 2006
Waters Obtains ISO 13485 Certification
for QMS
Waters Corporation has announced two major initiatives aimed at servicing the clinical laboratory at the American Association for Clinical Chemistry (AACC) 2006 Annual Meeting
First, Waters has initiated a number of clinical studies evaluating the safety and efficacy of its MassTrak Immunosuppressant Kit for tacrolimus in the United States This is the first reagent kit designed specifically for use with tandem mass spectrometry (MS) for the analysis of an immunosuppressive drug
This article was originally published on Laboratorytalk on 2 Aug 2004 at 8.00am (UK)
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Tacrolimus is widely used to prevent organ rejection following transplantation.
Tandem MS uses molecular mass to precisely measure tacrolimus levels in whole blood, which is a vital for effective management of transplant patients.
According to Dr James C.
Ritchie, Core Laboratory Director and Director of Special Chemistry at Emory University (Atlanta, Georgia), "Liquid chromatography(LC)/tandem MS is a universally better technology for immunosuppressants than what is currently offered today".
"More and more academic centers and large research hospitals are turning to liquid chromatography/tandem MS because of its ease-of-use, ability to turn samples around quickly and return-on-investment." Waters also announced it has achieved ISO 13485 certification for its Quality Management System (QMS).
To meet this global medical device standard, the company underwent an audit by Lloyd's Register Quality Assurance .
of its quality management system for the entire lifecycle of its LC and LC/MS instruments, chemistries and applications software.
According to Michael Yelle, Senior Director of Clinical Business Operations at Waters, "Today's announcements highlight the latest in a series of investments the company has made to serve the clinical laboratory market".
"Over the past ten years, Waters has built a team of dedicated application chemists that has developed and validated numerous clinical assays".
"The company has also recently formed a clinical service and support group dedicated to serving clinical laboratories.".
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