Mitra®

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 use.

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Harpera™

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.

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hemaPEN®

hemaPEN^® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD. Outside of the territories listed above, the hemaPEN is supplied for research use only (RUO) and not for therapeutic or diagnostic use.

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Mitra^®, VAMS^® & hemaPEN^® are registered trademarks owned by Trajan Scientific Australia Pty Ltd