NEW YORK (GenomeWeb News) – Agilent Technologies said today it has received ISO 13485 certification for the manufacture of its liquid chromatography-mass spectrometry systems.
Calling it the latest step in the company's efforts to move its life science tools into the clinic, Gustavo Salem, vice president and general manager of the firm's Biological Systems Division, said Agilent also is in talks with the US Food and Drug Administration "about requirements for clearing a number of our platforms, and we're being very methodical and deliberate about this."
Certification covers manufacturing of all of Agilent's LC-MS systems including its 6100 Series quadrupole and 6400 Series triple-quadrupole platforms.
Agilent received ISO 13485 certification for the design and manufacture of its DNA microarrays and microarray scanner platform in March 2010. Its analytical instrumentation systems and microarrays systems produced at its Santa Clara, Calif., facilities have been manufactured under an ISO 9001:2008-certified quality management system since 2009.
Most recently, Agilent in June registered its 80,000 square-foot manufacturing plant in Cedar Creek, Texas with the FDA as a medical device establishment.