AB SCIEX, a provider of analytical technologies, has received ISO 13485 certification for manufacturing LC/MS Systems.
The company said it currently manufacture and sells LC/MS/MS systems for research use only.
AB SCIEX said the ISO 13485 certification covers its manufacturing facility in Singapore and its R&D design center in Toronto, Canada.
AB SCIEX president Rainer Blair said the company is taking the necessary steps to be compliant with regulatory requirements that will govern its entry into clinical diagnostics.
"Achieving the ISO 13485 certification is an important measure toward realizing the vision of our LC/MS/MS systems to be cleared for use in clinics," Blair said.
"The potential impact of mass spectrometry technologies on clinical diagnostics is significant."