Agilent Microarray Manufacturing Achieves ISO 13485 Compliance; Cytogenetics Platform Poised to Pursue FDA 510(k) Clearance

“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 the leading provider of microarray-based solutions for cytogenetics testing, we remain committed to our customers in providing the highest quality of product and support in this market,” said Gustavo Salem, Agilent vice president and general manager, Biological Systems Division. “We believe that Agilent is in a strong position to take the next step in our dialog with the U.S. FDA toward pursuing clearance for a cytogenetics device based on Agilent’s platform.” 

Agilent 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.