NEW YORK (GenomeWeb News) – Shimadzu said today that it has registered several of its HPLC and LC-MS instruments as Class I medical devices with the US Food and Drug Administration, allowing them to be used in clinical settings.
The registration covers Shimadzu's LC-20 CL and LC-30 CL HPLCs; LC-MS-2020 CL single quadrupole mass spec; and LC-MS-8030 CL, LC-MS-8040 CL, and LC-MS-8050 CL triple quadrupole mass specs.
These are the first instruments the company has registered with FDA as medical devices, a move it said it made in response to growing demand for "analytical measurement in healthcare applications."
Several other major life science mass spec vendors including Waters, Agilent, and AB Sciex have also registered devices with FDA. The agency began in 2011 requiring that manufacturers register instruments intended for use in a clinical setting.