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

Neoteryx EU authorized representative update

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Company Press Release, Product Press Release

Neoteryx EU authorized representative update

April 10,2025 1 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.

Harpera™ Microbiopsy™ Punch is a manual surgical device intended to enable the collection of a specimen from the cutaneous skin surface by a healthcare professional. FDA-registered for marketing in the US, Harpera is made available as an investigational use only (IUO) product for use in performance studies outside of the US.

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).

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