Waters, a US-based laboratory analytical instrument and software company, has obtained the Chinese Food and Drug Administration (CFDA) approval for its Acquity Uplc TQD system for routine diagnostic applications and neonatal metabolites diseases screening.
An UltraPerformance LC/tandem quadrupole mass spectrometry (UPLC/MS/MS) system, the Acquity Uplc TQD is a tandem-quadrupole, mass detector-based system.
The ultra-compact system is developed for routine UPLC/MS/MS analyses and quantitative applications featuring high levels of MS selectivity, robustness, speed, and accuracy.
Waters worldwide marketing and informatics vice president Dr Rohit Khanna said that 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," Dr Khanna added.
"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."
Waters had received the CFDA approval for a neonatal screening solution inclusive of the Waters Quattro micro mass spectrometer in 2008.