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the microsampling blog / therapeutic drug monitoring

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.

therapeutic drug monitoring for methadone maintenance programs

by Neoteryx | 2 min read

therapeutic drug monitoring for methadone maintenance programs

Methadone is one of the medications approved by the US Food and Drug Administration (FDA) for use in the treatment of Opioid Use Disorder (OUD). It is a long-acting opioid …

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TDM in Europe gets a boost from remote microsampling

by Neoteryx | 3 min read

TDM in Europe gets a boost from remote microsampling

Kang and Lee define TDM (therapeutic drug monitoring) as a clinical laboratory measurement of a particular drug in a patient’s bloodstream that, with proper medical interpretation and optimized and individualized …

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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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