Chinese FDA approves ACQUITY UPLC TQD system for routine diagnostic
applications and neonatal metabolites diseases screening
MILFORD, Mass.--(BUSINESS WIRE)--Jun. 5, 2014--
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
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
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.
Source: Waters Corporation
Jeff Tarmy, +1-508-482-2268