LC and Mass Spec Systems Listed as Class I Medical Devices with FDA

Agilent Technologies, Inc 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 US 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.