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Mitra® devices are intended as a specimen collector and for the storage and transport of biological fluids. They are CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia, Brazil & China, Class B in South Africa, and registered with health agencies in Canada, Thailand, and Ukraine. In the United States, Mitra devices are for Research Use Only (RUO). In some countries, Mitra devices may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. Mitra is a registered trademark of Neoteryx, LLC. hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research use only (RUO) and not for therapeutic or diagnostic use. hemaPEN® is a registered trademark owned by Trajan Scientific Australia Pty Ltd.
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