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ABOUT NEOTERYX
Neoteryx LLC, a medical device company in Southern California, delivers simple, quantitative and automatable microsampling solutions. Its Mitra® device facilitates remote specimen collection and transportation of blood and other biological fluids to improve human health, reduce laboratory costs and enable new models of care. Neoteryx’s customers include scientific researchers, laboratories and health providers working to advance telemedicine, pharmaceutical development, biotechnology research and clinical diagnostics. Visit www.neoteryx.com for more information.
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Trajan Scientific Americas Inc.
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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 entities in the Trajan Group.
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