US FDA listing of Trajan’s hemaPEN blood microsampling device

US FDA listing of Trajan’s hemaPEN blood microsampling device

July 02, 2020

Trajan Scientific and Medical (Trajan) has listed its hemaPEN® blood microsampling device with the U.S. Food and Drug Administration (US FDA) as Class I for therapeutic and in vitro diagnostic (IVD) use.

This follows the hemaPEN’s recent registration in May for supply in the EU and UK as a General IVD; as well as inclusion in the TGA’s ARTG (Australian Register of Therapeutic Goods) in February as a Class I IVD.

This enables hemaPEN to be used to collect blood microsamples for clinical trials, diagnostics and applications to monitor health.

hemaPEN provides a convenient sampling procedure for collection and storage of four dried blood spot (DBS) samples. Unlike conventional DBS sampling tools, hemaPEN enables collection of an accurate and precise fixed micro-volume and is designed to maintain sample integrity for quantitative analysis. An easy-to-use sophisticated microsampling tool in the hands of non-analysts.

Remote microsampling facilitates more flexible blood sampling compared to traditional phlebotomy (blood draw) for scientific and clinical communities, for rapid R&D and implementation of new healthcare solutions for the public.

Trajan believes in science that benefits people – creating portable and affordable measurement solutions, enabling accurate results to inform preventative healthcare.

Visit www.hemapen.com to purchase or learn more about hemaPEN, and to sign up for updates.

To learn more about Trajan’s microsampling technologies and capabilities visit www.trajanscimed.com/microsampling.




Also in News

Advantages of hemaPEN blood microsampling validated for therapeutic drug monitoring in RSC’s Analyst
Advantages of hemaPEN blood microsampling validated for therapeutic drug monitoring in RSC’s Analyst

September 07, 2020

Trajan Scientific and Medical’s hemaPEN® has been independently evaluated and the results of the study published in the Royal Society of Chemistry’s journal Analyst - selected for the cover of issue 17. hemaPEN demonstrated significant advantages for blood sampling to support better healthcare decision making.

Read More

European patent for Trajan’s hemaPEN
European patent for Trajan’s hemaPEN

July 13, 2020

Trajan Scientific and Medical is proud to advise that the European Patent Office will be granting a patent for hemaPEN® as a liquid collection device in Belgium, France, Germany, Ireland, Luxembourg, Monaco, Switzerland, Liechtenstein and the United Kingdom. Extensions are being sought across the remainder of Europe.

Read More

CE mark for Trajan’s hemaPEN blood microsampling device, now available for diagnostic use across EU and UK
CE mark for Trajan’s hemaPEN blood microsampling device, now available for diagnostic use across EU and UK

May 07, 2020

Trajan Scientific and Medical has declared hemaPEN compliance with EU IVD Directive 98/79/EC, and its release for in vitro diagnostic use in the EU and UK. This follows the hemaPEN’s recent addition to the TGA’s ARTG (Australian Register of Therapeutic Goods) in February as a Class 1 IVD device.

Read More