The unmet need

by Professor Tarl Prow, Director of the Centre for Skin Research at the University of York

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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).