 |
| Agilent 6100 Series |
 |
| Agilent 6400 Series |
Agilent
Technologies Inc. (NYSE: A) recently announced that its liquid chromatography/mass
spectrometry systems, including 6100 Series single quadrupole and 6400 Series triple quadrupole systems, are now manufactured under ISO 13485
certification. This is an internationally recognized standard of quality management
for the design and manufacture of medical devices.
"This
is just the latest step that Agilent has taken to clear the way for use of our
life science tools in the clinic," said Gustavo Salem, Agilent vice
president and general manager, Biological Systems Division.
"We're
also in talks with the FDA about requirements for clearing a number of our
platforms, and we're being very methodical and deliberate about this."
"These
systems are well-proven in toxicology, clinical research, metabolomics,
proteomics and chemical analysis," added John Fjeldsted, Agilent general
manager, LC/MS. "There's value in having the additional validation of an
ISO 13485-registered quality management system on top of our own high standards
of quality design and manufacturing as we pursue approval for the clinic."
In
March 2010, Agilent achieved ISO 13485 certification for the design and
manufacture of its entire portfolio of DNA microarrays and microarray scanner
platform. In June 2011, Agilent announced that its Cedar Creek, Texas, reagent
manufacturing facility has been registered with the U.S. Food and Drug
Administration as a medical device establishment. This registration is required
for the manufacture of diagnostic products.
About Agilent
Technologies
Agilent
Technologies Inc. (NYSE: A) is the world's premier measurement company and a
technology leader in chemical analysis, life sciences, electronics and
communications. The company's 18,500 employees serve customers in more than 100
countries. Agilent had net revenues of $5.4 billion in fiscal 2010. Information
about Agilent is available at www.agilent.com.
No comments:
Post a Comment