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Mitra® devices are CE-IVD (IVDR) devices intended as specimen collectors and for the storage and transport of dried blood. They are available as registered IVD Devices in the European Union and United Kingdom, Australia, Brazil, China, 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. Mitra has not been validated for use with any diagnostic testing.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™ skin microbiopsy tool is currently supplied as an investigational use only (IUO) product globally.