Agilent Technologies has received the ISO 13485 certification to manufacture liquid chromatography/mass spectrometry systems, including 6100 Series single quadrupole and 6400 Series triple quadrupole systems.
Agilent is a measurement company operating its businesses through three units including Chemical Analysis, Life Sciences and Electronic Measurement.
The company’s Agilent Research Laboratories is engaged in conducting research that anticipates customer needs.
Agilent Biological Systems Division vice president and general manager Gustavo Salem said they are also in talks with the FDA about requirements for clearing a number of their platforms.
Agilent LC/MS general manager John Fjeldsted said these systems are well-proven in toxicology, clinical research, metabolomics, proteomics and chemical analysis.
"There’s value in having the additional validation of an ISO 13485-registered quality management system on our own quality design and manufacturing as we pursue approval for the clinic," Fjeldsted said.