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

Booster for At-Risk

The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people 65 and older or at increased risk.

Preprints OK to Mention Again

Nature News reports the Australian Research Council has changed its new policy and now allows preprints to be cited in grant applications.

Hundreds of Millions More to Share

The US plans to purchase and donate 500 million additional SARS-CoV-2 vaccine doses, according to the Washington Post.

Nature Papers Examine Molecular Program Differences Influencing Neural Cells, Population History of Polynesia

In Nature this week: changes in molecular program during embryonic development leads to different neural cell types, and more.