Agilent Technologies’ LC/MS Manufacturing Achieves ISO 13485 Certification
Agilent Technologies announced that its liquid chromatography/mass spectrometry systems, including 6100 Series single quadrupole and 6400 Series triple quadrupole systems, are now manufactured under ISO 13485 certification. This is an internationally recognized standard of quality management for the design and manufacture of medical devices.
In March 2010, Agilent achieved ISO 13485 certification for the design and manufacture of its entire portfolio of DNA microarrays and microarray scanner platform. Agilent analytical instrumentation systems and microarray systems produced at the company's Santa Clara, Calif., facilities have been manufactured under an ISO 9001:2008-certified quality management system since April 2009. In June 2011, Agilent announced that its Cedar Creek, Texas, reagent manufacturing facility has been registered with the U.S. Food and Drug Administration as a medical device establishment. This registration is required for the manufacture of diagnostic products.