Newsroom / Coronavirus

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.

COVID-19 Screening Before Re-Entry to Work, School, Military

by Christa Nuber, on July 8,2020

Blood collection for COVID-19 testing aims to protect employees, students and soldiers. As businesses, universities and the Armed Forces begin reopening during the coronavirus pandemic—before a working vaccine against COVID-19 …

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University of Rochester Examines Blood to Detect COVID-19 Antibodies

by Neoteryx, on April 27,2020

ROCHESTER, NY — Researchers around the globe are racing to respond to the COVID-19 pandemic. At the University of Rochester in the Clinical and Translational Science Institute (CTSI), researcher and …

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NIH Begins Study to Quantify Undetected Cases of Coronavirus Infection

by Neoteryx, on April 10,2020

BETHESDA, MD — A new study has begun recruiting at the National Institutes of Health in Bethesda, Maryland to determine how many adults in the United States without a confirmed …

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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.

Copyright © 2020 Neoteryx, LLC. All rights reserved.

Newsroom / Coronavirus

COVID-19 Screening Before Re-Entry to Work, School, Military

University of Rochester Examines Blood to Detect COVID-19 Antibodies

NIH Begins Study to Quantify Undetected Cases of Coronavirus Infection

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