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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 content.

how microsampling improves clinical research

by Neoteryx | 3 min read

how microsampling improves clinical research

Microsampling is a method of specimen collection that allows nearly anyone to collect tiny (or “micro-sized”) specimen samples for lab analysis. Microsampling is suitable for remote specimen collection for decentralized …

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7 wellness tests that are possible with dried blood samples

by Neoteryx | 4 min read

7 wellness tests that are possible with dried blood samples

Why go to the lab or blood draw clinic if you don't have to? Many health and wellness companies now offer home health kits that enable you to collect your …

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veterinary medicine: portable blood sampling for farm animals & livestock

by Neoteryx | 2 min read

veterinary medicine: portable blood sampling for farm animals & livestock

The world population is expected to grow to 9 billion people by 2050. This means that food production needs to increase proportionately, by at least 60%, to feed an increased …

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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.