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Mitra® devices are intended as a specimen collector and for the storage and transport of blood. They are CE-IVD 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 and Ukraine.
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. The suitability of Mitra for any analytical application must be evaluated and validated by the laboratory or research institute in a manner consistent with local regulatory requirements.
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.
Mitra®, VAMS® & hemaPEN® are registered trademarks owned by Trajan Scientific Australia Pty Ltd. Copyright © 2022. All rights reserved.