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.