by Neoteryx, on August 27,2020
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 …
Read Storyby Neoteryx, on August 14,2020
LOS ANGELES—Medical device company Neoteryx has a reputation for providing extraordinary customer service and support to its scientific and healthcare customers in research, clinical trials, laboratory services, and payer/provider networks. Many …
Read StoryIf you don’t find the information & assets you need via the buttons below, please contact us here: press@neoteryx.com
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.
Copyright © 2019 Neoteryx, LLC. All rights reserved.