NEW YORK (GenomeWeb News) – Waters said today that the Chinese Food and Drug Administration has approved registration of its Acquity UPLC TQD system for sale as a medical device for routine diagnostic applications and neonatal metabolites disease screening.
The device is the second of Waters to receive Chinese approval for in vitro diagnostic applications. In 2008, the CFDA approved a neonatal screening test on the company's Quattro micro mass spec.
The approval "reinforces Waters' strategy of expanding applications of our core chromatography and mass spectrometry technologies throughout the world," Rohit Khanna, the company's vice president of worldwide marketing and informatics, said in a statement. He noted that the Acquity UPLC TQD system is now registered as a medical device in 59 countries.
The Acquity UPLC TQD is a benchtop, tandem-quadrupole, mass detector-based system designed for routine UPLC/MS/MS analyses and quantitative applications.