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Posts in Remote Patient Monitoring

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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 content.

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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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