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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The human immune system is conditioned to attack anything it identifies as "foreign." When a patient receives an organ transplant, their immune system typically identifies the new organ as foreign, …
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Immunosuppressive drugs are mandatory when a patient is going through procedures like organ or tissue transplantation, chemotherapy, or suffering from autoimmune diseases. This is because ISP drugs have a narrow …
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Expert interpretation of drug concentration is critical to understanding pharmacokinetics and realizing full its clinical benefits. Clinicians achieve this by monitoring drug pharmacodynamics routinely and measuring physiological indices of therapeutic responses directly. However, …
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Over the past five decades, the medical community has witnessed considerable advancements in organ transplants. Patients receive organs, and through immunosuppressive drugs, their bodies can accept the organ. Therefore, the …
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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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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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