Agilent Technologies Inc. (NYSE:A) today announced that it has listed
its Infinity
Series 1200 liquid chromatography systems and 6000 Series mass
spectrometry systems as Class I medical devices with the U.S. Food and
Drug Administration.
"The latest generation of liquid chromatography and mass spec systems
that Agilent has registered holds tremendous value for the medical
community,” said Gustavo Salem, Agilent vice president and general
manager, Biological Systems Division. "We’re being very methodical in
bringing this technology to the clinic, while ensuring that the
equipment meets the laboratories’ needs.”
The Infinity Series1200 is manufactured in Waldbronn, Germany, and the
6000 Series is manufactured in Singapore. Both facilities are registered
as medical device establishments with the FDA, a requirement for
manufacturing medical devices. In September 2011, those facilities were
certified as meeting the internationally recognized ISO 13485
quality-management standard. In June 2011, Agilent’s reagent
manufacturing facility in Cedar Creek, Texas, was registered with the
FDA as a medical device establishment.
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 18,700 employees serve
customers in more than 100 countries. Agilent had net revenues of $6.6
billion in fiscal 2011. Information about Agilent is available at www.agilent.com.
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