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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.

Wellness Company 'for you eHealth' Offers Immunity Home Testing Kits

by Neoteryx, on August 27,2020

Wellness Company 'for you eHealth' Offers Immunity Home Testing Kits

LOS ANGELES & WEIDEN, Germany – August 2020 – for you eHealth, an online health & wellness company based in Germany, today launched an at-home immunity blood test kit that …

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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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