Analysis
Agilent Microarray Manufacturing Achieves ISO 13485 Compliance; Cytogenetics Platform Poised to Pursue FDA 510(k) Clearance
Agilent today announced that its entire portfolio of DNA microarrays is now manufactured under ISO 13485 certification, an internationally recognized standard for quality management systems (QMS). Agilent has always emphasized quality in the manufacture of microarrays, and we're very pleased to be adding the validation of an ISO 13485-registered QMS on top of our existing ISO 9001 standard, said Robert Schueren, Agilent vice president and general manager, Genomics and Life Science Reagents.
As tAgilent is a leading global provider of microarrays for studying gene expression, comparative genomic hybridization, copy number variations, microRNA, chromatin immunoprecipitation, methylation, and custom assays, as well as scanners and software.
Agilent analytical instrumentation systems and microarray systems produced at the company's Santa Clara facilities have been manufactured under an ISO 9001:2008 certified QMS since April 2009.