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.
by Neoteryx | 2 min read
The National Drug-Free Workplace Alliance reports that over 74% of illegal drug users are employed. These employees who use drugs contribute to about 40% of all industrial fatalities in the United …
Read Storyby Neoteryx | 3 min read
While drug and alcohol abuse affect many aspects of a society, they can be particularly detrimental in work settings. Employees may reduce productivity, causing a company’s revenue to plummet. According …
Read StoryLearn about insights, research, case studies, and tutorials on integrating remote specimen collection, microsampling, and more!
421 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.