by Neoteryx | 1 min read
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 | 1 min read
The Mitra® microsampling device, based on Volumetric Absorptive Microsampling (VAMS™) technology developed by Neoteryx, is a simple instrument. It collects small, volumetrically accurate specimens of blood (and other biological fluids) and allows for remote sampling, taking blood collection out of the clinic.
This provides blood collection, shipping, and storage solution that is in many respects superior to what came before. What's more interesting is what it means for clinical trials, clinical diagnostics, and the entire spectrum of medical research, precision medicine, patient-centered care, and health and wellness.
This video provides:
See for yourself how blood microsampling is inspiring new conversations, opening new pathways of care, and connecting the potential of new technologies with the stuff of human life.
Originally published Mar 26, 2019 9:20:28 AM, updated on March 27, 2019
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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.
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