With confirmation from our Notified Body, QMD Services GmbH (NB 2962), our PEth LC-MS/MS Kit A371 has reached a decisive milestone: It is covered by our existing EU QMS certificate and can be placed on the market as a CE-marked in vitro diagnostic device in accordance with the IVDR.

This success represents more than just regulatory compliance—it signifies the successful transition from research to clinical application. We are bringing a highly standardized, validated, and quality-assured solution for PEth analysis into everyday clinical practice.

Our kit enables the precise quantitative determination of the relevant PEth homologs (PEth 16:0/18:1 and PEth 16:0/18:2) in whole blood using LC-MS/MS, thereby setting a new standard for the reliable assessment of individual long-term alcohol consumption.

We listened to you—our users, our customers, and our partners.
We developed, extensively tested, and created a product that more than meets the requirements of both the laboratory and the clinical setting—a product, we are justifiably proud of.

A big thank you to our team, all our partners, and customers who believed in us and joined us on this journey from the initial idea through the RUO phase to today’s IVDR-compliant product.
But the journey doesn’t end here—further development efforts surrounding PEth have begun to ensure its commercial success worldwide.

Feel free to follow us on LinkedIN —stay tuned!
For more details download the brochure from: https://www.archimedline.com/en/peth-lc-msms-kit-whole-blood/