EduBourseActualitésAgilent Microarray Manufacturing Achieves ISO 13485 Compliance; Cytogenetics Platform Poised to Pursue...

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

Pierre Perrin-Monlouis Dernière mise à jour: 20 octobre 2021

Agilent Technologies Inc. (NYSE: A) 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 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.

About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is the world’s premier measurement company and a technology leader in communications, electronics, life sciences and chemical analysis. The company’s 16,000 employees serve customers in more than 110 countries. Agilent had net revenues of $4.5 billion in fiscal 2009. Information about Agilent is available on the Web at

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Stuart Matlow
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Pierre Perrin-Monlouis
Pierre Perrin-Monlouis
Fondateur de Rente et Patrimoine (cabinet de gestion de patrimoine), Pierre Perrin-Monlouis est un analyste et trader pour compte propre. Il vous fait profiter de son expérience en trading grâce à ses analyses financières et décrypte pour vous les actualités des marchés. Son approche globale des marchés combine à la fois l'analyse technique et l'analyse fondamentale sur l'ensemble des marchés : crypto, forex, actions et matières premières.