Waters products manufactured as per US FDA and CE-Marked standards

Waters Corporation announced that the Waters Acquity UPLC I-Class IVD/Xevo TQ-S micro IVD System is now manufactured as a US FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). This development will allow clinical laboratories to access 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.

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 of LC-MS 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 confirmation of those analytes. The ACQUITY UPLC I-Class IVD/Xevo TQ-S micro IVD System features Waters’ UltraPerformance LC technology coupled with a benchtop tandem-quadrupole mass spectrometer designed to provide the highest acquisition rates in UPLC-MS/MS quantitative analysis. Xccelerated Ion Transfer (XIT) electronics, using SpaceWire technology, allow this instrument to acquire data at high speeds without compromising performance, and extensions to tried-and-tested StepWave ion optics continue Waters’ long history in the delivery of sensitive and robust LC-MS systems.

Contact Details:
Dayamani Santosh
Sr. Admin. Officer
Waters India
36A, II Phase, Peenya Indl Area
Bangalore – 560 058
Tel: 080 – 49292200-03
Fax: 080 – 49292204
Mob: 96327 86899
Email: dayamani_santosh@waters.com
Website: www.waters.com