Skip to main content
Premium Trial:

Request an Annual Quote

Agilent Achieves ISO 13485 Certification for LC-MS Manufacturing

NEW YORK (GenomeWeb News) – Agilent Technologies said today it has received ISO 13485 certification for the manufacture of its liquid chromatography-mass spectrometry systems.

Calling it the latest step in the company's efforts to move its life science tools into the clinic, Gustavo Salem, vice president and general manager of the firm's Biological Systems Division, said Agilent also is in talks with the US Food and Drug Administration "about requirements for clearing a number of our platforms, and we're being very methodical and deliberate about this."

Certification covers manufacturing of all of Agilent's LC-MS systems including its 6100 Series quadrupole and 6400 Series triple-quadrupole platforms.

Agilent received ISO 13485 certification for the design and manufacture of its DNA microarrays and microarray scanner platform in March 2010. Its analytical instrumentation systems and microarrays systems produced at its Santa Clara, Calif., facilities have been manufactured under an ISO 9001:2008-certified quality management system since 2009.

Most recently, Agilent in June registered its 80,000 square-foot manufacturing plant in Cedar Creek, Texas with the FDA as a medical device establishment.

The Scan

Purnell Choppin Dies

Purnell Choppin, a virologist who led the Howard Hughes Medical Institute, has died at 91, according to the Washington Post.

Effectiveness May Decline, Data From Israel Suggests

The New York Times reports that new Israeli data suggests a decline in Pfizer-BioNTech SARS-CoV-2 vaccine effectiveness against Delta variant infection, though protection against severe disease remains high.

To See Future Risk

Slate looks into the use of polygenic risk scores in embryo screening.

PLOS Papers on Methicillin-Resistant Staphylococcus, Bone Marrow Smear Sequencing, More

In PLOS this week: genomic analysis of methicillin-resistant Staphylococcus pseudintermedius, archived bone marrow sequencing, and more.