Eyeing Clinical Market, AB Sciex Obtains ISO 13485 Certification for LC-MS Facilities | GenomeWeb

This story originally ran on Feb. 27.

AB Sciex said this week that it has achieved ISO 13485 certification for its quality management system, a key step in obtaining European regulatory clearance for clinical use of its liquid chromatography and mass spectrometry instruments.

The company's LC-MS systems are currently for research use only, but, AB Sciex president Rainer Blair said in a statement, the company "is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics."

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