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All Topics Microsampling Mitra® Device Industry News, Microsampling News Company Press Release, Product Press Release Research, Remote Research Infectious Disease, Vaccines, COVID-19 Clinical Trials, Clinical Research Blood Microsampling, Serology Biomonitoring, Health, Wellness Decentralized Clinical Trial (DCT) Omics, Multi-Omics Venipuncture Alternative Specimen Collection Toxicology, Doping, Drug/Alcohol Monitoring, PEth Harpera® Tool Pharmaceuticals, Drug Development Skin Microsampling, Microbiopsy Therapeutic Drug Monitoring, TDM Antibodies, MAbs Environmental Toxins, Exposures Preclinical Research, Animal Studies hemaPEN® Device

Trajan’s Microsampling Devices Earn CE-IVD Registration in Europe, UK

Mitra devices earn IVDR CE Mark in EU & UK

Company Press Release, Product Press Release

Trajan’s Microsampling Devices Earn CE-IVD Registration in Europe, UK

June 2,2023 3 min read

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Mitra | Blood Collection
hemaPEN | Blood Collection
Harpera | Skin Biopsy
GTR-NEO | RNA Preservation

Mitra® devices are CE-IVD (IVDR) devices intended as a specimen collector, and for the storage and transport of blood and other biological fluids for analytical and diagnostic analyses. They are available as registered IVD Devices in the European Union and United Kingdom, Australia, Brazil, China, Israel, Colombia, South Africa, and Canada, as well as multiple Health Ministries worldwide. In the USA, Mitra devices are supplied as a research use only (RUO) product to assist in method development, other research-related and non-diagnostic activities. End-users and laboratories must validate the use of the Mitra devices for the particular diagnostic testing intended.

hemaPEN® variants are CE-IVD (IVDR) devices intended as specimen collectors, for the storage and transport of dried blood specimens and are available as registered IVD Devices in the European Union and United Kingdom, Australia/New Zealand, and the USA. Outside of these territories, the hemaPEN is supplied for research use only (RUO).

The Harpera™ Microbiopsy^TM Punch is intended to enable the collection of a specimen from the cutaneous skin surface by a healthcare professional for clinical studies and is currently supplied as an investigational use only (IUO) product globally

Mitra®, VAMS® & hemaPEN® are registered trademarks owned by Trajan Scientific Australia Pty Ltd. Copyright © 2024. All rights reserved.