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

Trajan acquires HDExaminer Software from California-based, Sierra Analytics Inc.
Trajan acquires HDExaminer Software from California-based, Sierra Analytics Inc.

February 15, 2023

Trajan Scientific and Medical announces the completion to acquire specialized software business, HDExaminer, from California-based, Sierra Analytics, Inc.

Read More

Trajan collaborates with Monash University for the development of HDX training centre
Trajan collaborates with Monash University for the development of HDX training centre

February 03, 2023

Trajan Scientific and Medical with Monash University would like to announce a collaboration for the development of an HDX training centre at Monash University's Proteomics and Metabolomics Facility (MPMF). This collaboration will provide the university with access to a Trajan HDX system and allow Trajan to provide HDX training to the proteomics community in the region.

Read More

Baker Institute research leads to simple tests for heart and diabetes disease
Baker Institute research leads to simple tests for heart and diabetes disease

January 13, 2023

Collaboration has been key to a global health innovation to counter cardiovascular disease. One of Australia’s leading research facilities, the Baker Heart and Diabetes Institute, had the technology to potentially revolutionise testing for heart disease and diabetes, using just a single drop of blood. All it lacked for this global breakthrough was commercial nous, developmental infrastructure and marketing know-how. On the other hand, Trajan Scientific and Medical, a Melbourne-based ASX biotech company, had the technology and expertise to take products to market.

Read More