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Agilent Technologies Lists LC and Mass Spec Systems as Class I Devices with FDA

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“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.