In the US, use of the Mitra device is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device can be used as a sample collection device for clinical diagnostic applications, as referenced in some content included here.
Children can find visits to a research facility stressful. This poses challenges for researchers and trial managers who rely on collecting bio-fluid specimens to monitor pediatric study subjects. One solution is to offer remote specimen collection, which reduces or eliminates onsite visits. Remote specimen collection can be performed by parents or another family member at home, which makes the process less stressful. The Mitra® Microsampler is a portable device designed for easy sampling at home or on the go. Samples can be mailed back to the facility via regular post for lab analysis. This remote option provides a better experience for young study participants and their families, and a convenient way for researchers to gather the high-quality samples they need to generate reliable data.
Learn more about the remarkable results already being achieved by researchers at Gaslini Children's Hospital, Swiss Tropical and Public Health Institute, and others. Some case studies offered here for download discuss healthcare projects in countries outside the US, where Mitra® devices are approved for blood collection in clinical settings:
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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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