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Waters Corporation. (6/5/14). "Press Release: Waters Acquity UPLC TQD System Receives Medical Device Approval in China". Milford, MA.

Region Region China
Organisations Organisation Waters Corporation (NYSE: WAT)
  Group Waters (Group)
  Organisation 2 CFDA (Chinese Food and Drug Administration)
  Group China (govt)
Products Product ACQUITY® TQD Triple Quadrupole Mass Spectrometry System
  Product 2 clinical mass spectrometry-based test
Persons Person Khanna, Rohit (Waters 201601– SVP Applied Technology before VP Worldwide Marketing)
  Person 2 Tarmy, Jeff (Waters 201005)
     


Chinese FDA approves ACQUITY UPLC TQD system for routine diagnostic applications and neonatal metabolites diseases screening


Waters® Corporation (NYSE: WAT) today announced that the Chinese Food and Drug Administration (CFDA) approved the registration of the ACQUITY UPLC® TQD system for legal promotion and sale in China as a medical device for routine diagnostic applications and neonatal metabolites diseases screening.

A continuation of Waters' commitment to China and to growing clinical LC-MS applications worldwide, this registration represents the second Waters' mass spectrometer approved for in vitro diagnostic (IVD) applications in China. In 2008, the CFDA (formerly known as the SFDA) approved a neonatal screening solution inclusive of the Waters Quattro micro™ mass spectrometer.

"The approval by the CFDA of ACQUITY UPLC MS/MS system as a medical device is significant for two reasons. First and most importantly, this registration opens the door for millions of Chinese citizens to benefit from the gold standard of LC-MS diagnostic analysis," said Dr. Rohit Khanna, Vice President of Worldwide Marketing and Informatics. "Secondly, this commitment to China's analytical scientists and laboratories reinforces Waters' strategy of expanding applications of our core chromatography and mass spectrometry technologies throughout the world. As of this decision by the CFDA, the ACQUITY UPLC, MS/MS system is registered as a medical device in 29 countries plus the European Economic Area, which includes an additional 30 countries."

An UltraPerformance LC®/tandem quadrupole mass spectrometry (UPLC®/MS/MS) system, the ACQUITY UPLC TQD is a benchtop, ultra-compact, tandem-quadrupole, mass detector-based system designed for routine UPLC/MS/MS analyses and quantitative applications featuring high levels of MS selectivity, robustness, speed, and accuracy.

For more information, please visit ACQUITY UPLC® TQD.


About Waters Corporation (www.waters.com)

For over 50 years, Waters Corporation (NYSE:WAT) has created business advantages for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, water quality, consumer products, and high value-added chemicals worldwide.

Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

With revenue of $1.9 billion in 2013, Waters is driving scientific discovery and operational excellence for customers worldwide.

Waters, ACQUITY, UPLC, Quattro micro and UltraPerformance LC are trademarks of Waters Corporation.


Waters Corporation
Jeff Tarmy, +1-508-482-2268
Corporate Communications
jeff_tarmy@waters.com

   
Record changed: 2016-03-19

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