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In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some of the news content posted here.

Neoteryx Expands European Footprint with Opening of Neoteryx B.V.

by Neoteryx, on January 21,2019

Neoteryx Expands European Footprint with Opening of Neoteryx B.V.

With significant worldwide growth in demand for microsampling technology, Neoteryx is opening new offices! We're expanding our European operations to better meet the needs of both new and existing customers …

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UK Initiative Offers At-home Microsampling Devices to Children

by Neoteryx, on November 12,2018

UK Initiative Offers At-home Microsampling Devices to Children

At-home blood sampling streamlines the process of therapeutic drug monitoring and creates comfort and emotional safety for children UNITED KINGDOM and TORRANCE, CA (November 07, 2018) – Neoteryx LLC, inventor of Volumetric …

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Mitra® is an exempt medical device in the US, CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia, and registered with Health Canada. It is intended as a specimen collector and for the storage and transport of biological fluids. Use of the device with blood for diagnostic applications is limited to certain countries and, in the US, for research and non-diagnostic purposes only. Neoteryx Products are not marketed in the US for clinical diagnostic uses. In other countries, Neoteryx Products may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.

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