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.
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Blood sampling is an invaluable part of clinical research, but blood collection methods and blood storage chains are resource-intensive and sometimes wasteful. Most traditional blood collection methods require in-patient visits …
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As the COVID-19 crisis continues to wreak havoc on public health, international relations and the world economy, all eyes are on our research scientists in the hope they can develop …
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When Fasha Mahjoor launched Neoteryx, he planned to change the way dried capillary blood is collected, to become the most significant blood microsampling innovator in the modern marketplace. In that, …
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Therapeutic drug monitoring (TDM) immunosuppressants are a critical component of post-tissue and organ transplantation therapy. This is because ISP drugs have high intra- and inter-subject variability and a narrow therapeutic …
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When administering immunosuppressants, clinicians need to individualize a patient’s drug therapy. The goal is to attain an optimal balance between therapeutic efficacy and the probability of adverse effects. Patients present …
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Patient-centric healthcare has taken center-stage. With the increasing access to information, patients want to play a role in treatment methods and applications. Patient-centric sampling has an important part to play …
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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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