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Waters LC, Mass Spec Systems Receive Approval for IVD Use in Brazil

NEW YORK (GenomeWeb) – Waters said today that Brazil's National Health Surveillance Agency (ANVISA) has approved several of the company's liquid chromatography and mass spectrometry systems for in vitro diagnostic use.

The ANVISA approval covers Waters' Acquity UPLC and Acquity UPLC I-Class systems, as well as its Xevo TQD, Xevo TQ-S micro, and Xevo TQ-S mass spectrometers, making them available for clinical use in Brazil.

"We are committed to expanding the number of Waters LC-MS systems listed and registered as IVD medical devices around the world that can support the changing practice of medicine and the laboratory tests that are used to proactively and preventatively diagnose and treat diseases," Jose Castro-Perez, director of health sciences marketing at Waters, said in a statement.

The company has previously registered its LC and MS instruments as medical devices with the US Food and Drug Administration and the Chinese FDA, and has received CE marking from the EU.