Informing Spectroscopists for Over 40 Years

Approval of Waters’ instrumentation for clinical use in Brazil

Brazil’s National Health Surveillance Agency (ANVISA) has approved certain of Waters’ chromatography system, as well as the Xevo® TQD, Xevo TQ-S micro and Xevo TQ-S1 mass spectrometers for in vitro diagnostic (IVD) use. Over recent years, the scope of use for IVD LC-MS instrument systems in the clinical environment has widened and the number of tests that can be developed and validated by diagnostic laboratory service providers has grown rapidly.

Waters’ LC-MS IVD instrument systems have previously been listed with US FDA, CE marked in Europe under the European Directive 98/79/EC (IVDD) and registered in China (registration of the ACQUITY UPLC I-Class/TQ-S micro IVD system is in process).

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