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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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Technique
