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Waters Registers LC-MS/MS System as Class I, CE-IVDD Marked Device

NEW YORK (GenomeWeb) – Waters said today that it is manufacturing its Acquity UPLC I-Class IVD/Xevo TQ-S Micro IVD LC-MS/MS system as a US Food and Drug Administration Class I medical device and CE-IVDD marked device.

These designations mean the system can be sold in the US and Europe for use in laboratory-developed tests including, for instance, protein-based diagnostics.

Waters was the first major mass spec vendor to register one of its instruments as a Class I device and has to date registered a number of its LC and LC-MS systems including its Acquity TQD and Xevo TQD instruments.

The company is "committed to expanding the number of Waters LC-MS systems listed as medical devices," Jeff Mazzeo, senior director, health sciences for Waters, said in a statement.

In addition to the designations announced today, in April 2015 Waters received Chinese FDA approval of the Acquity-Xevo TQ-S system for in vitro diagnostic use.