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Agilent Microarrays Receive ISO 13485 Certification

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Agilent Technologies has received certification from the International Organization for Standardization (ISO) for the manufacture of its DNA microarray portfolio, the company said today.

The ISO 13485 certification recognizes compliance with international quality management systems requirements.

Agilent's VP and GM of its Biological Systems Division, Gustavo Salem, said in a statement that the company now "is in a strong position to take the next step in our dialogue with the US [Food and Drug Administration] toward pursuing clearance for a cytogenetics device based on Agilent's platform."

Agilent provides microarrays for studying gene expression, comparative genomic hybridization, copy number variations, microRNA, chromatin, immunoprecipitation, methylation, custom assays, scanners and software.

The firm noted that its analytical instruments and microarray systems produced at its Santa Clara, Calif., facilities have been manufactured under an ISO 9001:2008 certification since April 2009.

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