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Waters Corporation. (6/8/17). "Press Release: Waters UPLC and Mass Spectrometry Systems Approved for In-Vitro Diagnostic Use in Brazil". Milford, MA.

Region Region Brazil
Organisations Organisation Waters Corporation (NYSE: WAT)
  Group Waters (Group)
  Organisation 2 ANVISA (National Health Surveillance Agency, Brazil)
Products Product ACQUITY UPLC I-Class/Xevo TQD IVD System
  Product 2 ACQUITY UPLC I-Class/Xevo TQ-S IVD System
Persons Person Castro-Perez, Jose (Danaher 202196 Senior Director LC/MS Accurate Mass Product Management before Waters
  Person 2 Haas, Karen (Waters 201601)

Clinical laboratories now have access to enhanced levels of selectivity, sensitivity, and versatility from Waters' newest UPLC-MS/MS technologies

Waters Corporation (NYSE: WAT) today announced that Brazil's National Health Surveillance Agency (ANVISA) has approved the Waters® ACQUITY® UPLC®, ACQUITY UPLC® I-Class System, and three mass spectrometers, the Xevo® TQD, Xevo TQ-S micro, and Xevo TQ-S1, for in-vitro diagnostic (IVD) use. This provides Brazil’s clinical laboratories access to leading innovations in liquid chromatography (LC) and mass spectrometry (MS) technology for the analysis of a variety of compounds that include diagnostic indicators in laboratory-developed tests.

"Waters was a pioneer in the use of LC-MS as medical devices over a decade ago," said Jose Castro-Perez, Director, Health Sciences Marketing at Waters. "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. We are pleased to make our IVD instruments available to scientists in Brazil.”

Using LC-MS technology, clinical laboratories perform qualitative and quantitative analyses of patients' samples to aid clinicians in many ways. 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. Liquid chromatography separates analytes and interferences within a given sample, while mass spectrometry technology is used for detection and quantification of those analytes. LC-MS technology is also commonly used in forensic toxicology testing.

Waters’ IVD medical devices are designed to optimize clinical laboratory workflows. The systems now available in Brazil include:

> ACQUITY UPLC I-Class/Xevo TQD IVD System, which is a rugged, robust, and reliable LC-MS clinical analyzer for routine quantitative analysis

> ACQUITY UPLC I-Class/Xevo TQ-S micro IVD System, which offers high LC-MS performance from a compact instrument design with rapid, reliable, and reproducible quantitative data

> ACQUITY UPLC I-Class/Xevo TQ-S IVD System, which enables accurate quantitative sensitivity for LC-MS analysis of samples with complex matrices or low concentrations that are commonly encountered in clinical laboratories

Waters’ LC-MS IVD instrument systems have previously been listed with U.S. 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).

About Waters Corporation

Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials and food sciences for nearly 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.

Waters, ACQUITY, UPLC, and Xevo are registered trademarks of Waters Corporation.

1. ANVISA Registration Numbers: ACQUITY UPLC IVD Instrument Family registration #no. 80102511713; Xevo Mass Spectrometer IVD Instrument Family registration #no. 80102511700; ACQUITY UPLC I-Class/Xevo TQ-S micro IVD System registration #no. 80102511694; and ACQUITY UPLC I-Class/Xevo TQ-S IVD System registration #no. 80102511692.

Waters Corporation
Karen Haas, 508-482-3363

Record changed: 2023-06-05


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