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 …
Read Storyby 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 …
Read Storyby 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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Fact Sheet & FAQs421 Amapola Ave
Torrance, CA 90501
Call us: 1 (310) 787-8747
info@neoteryx.com
The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is designed to be used by laboratory and healthcare professionals, or end-users as a container to collect and transport blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Microsampler in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.
The Mitra Microsampling Device is a FDA listed Class 1 exempt device, CE-IVD self-certified in the UK and EU, a Class I IVD in Australia, and registered with Health Canada. 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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