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 | 4 min read
Several vaccines for SARS-CoV-2, the virus that causes COVID-19 illness, have been developed, and are being made available. Because of this, many organizations are launching clinical studies to better understand …
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Remote clinical trials can help overcome the traditional obstacles and interruptions in clinical studies. The COVID-19 pandemic provided a new opportunity to pursue the remote approach to research. Remote specimen collection …
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Clinical trials are vital to advancing medical science, but they face many stumbling blocks. New technology has given researchers the ability to take clinical trials outside the trial site and …
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Organizing a clinical trial is no easy feat. Researchers must recruit a group of willing participants. The participants must meet the study criteria and be prepared to comply with all …
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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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Biological specimens like saliva, blood, or urine are often collected for use in routine patient monitoring and population surveys. Population surveys are essential because they provide current, detailed health and …
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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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