NEW YORK (GenomeWeb News) – Agilent Technologies today said that it has listed certain of its liquid chromatography and mass spectrometers as Class I medical devices with the US Food and Drug Administration.
The instruments that were listed are the company's Infinity Series 1200 LC platforms and 6000 Series mass specs. Class I classification is for devices that pose the least risk to patients and Class I devices are the least regulated under FDA's three classifications.
"The latest generation of liquid chromatography and mass spec systems that Agilent has registered holds tremendous value for the medical community, "Gustavo Salem, vice president and general manager of Agilent's Biological Systems Division, said in a statement. "We're being very methodical in bringing this technology to the clinic, while ensuring that the equipment meets the laboratories' needs."
The two systems are manufactured in facilities that are registered with FDA as medical device establishments, a requirement for manufacturing medical devices, Agilent said, adding that in September the facilities were ISO 13485 certified.
In June, Agilent registered its reagent manufacturing facility in Cedar Creek, Texas with FDA as a medical device establishment. At the time the company said it intended to manufacture diagnostic products.