Agilent LC/MS approved as a medical device

On January 17, 2012, Agilent Technologies Inc. stated that its liquid chromatographs and mass spectrometers have been approved by the US Food and Drug Administration (FDA) as Class I medical devices.

The approved instruments are the Infinity 1200 Series LC System and the 6000 Series Mass Spectrometry System. Class I indicates that the device poses the least risk to the patient, and Class I devices are the least regulated in the FDA's three classification regulations.

"Agilent's latest generation of liquid chromatography and mass spectrometry systems are of great value to the medical community," Gustavo Salem, Agilent's vice president and general manager of the Biosystems Division, said in a statement. “We are systematically applying this technology to the clinic while ensuring that it meets the needs of the laboratory.”

The Infinity 1200 Series LC system is manufactured at the Agilent facility in Germany and the 6000 Series mass spectrometry system is manufactured at the Agilent Singapore facility. Both factories are FDA-approved and registered as medical device manufacturing plants to meet the requirements of medical device manufacturing. In September 2011, these facilities also passed the internationally recognized ISO13485 quality management standard certification.

(Source: Instrument Information)

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