In the US, use of the Mitra device is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device can be used as a sample collection device for clinical diagnostic applications, as referenced in some content.
by James Rudge, PhD, Technical Director, Neoteryx | 5 min read
Simultaneous measurement of multi-antibody responses from dried blood samples. A study article published in the July 2021 issue of Frontiers in Immunology used Mitra samples collected from 54 study volunteers to measure antibody levels (IgA, IgG and IgM) raised from N and S antigens in: pre-pandemic, SARS-CoV-2 convalescence and vaccinated cohorts. The study, entitled “Antibody Mediated Immunity to …
Read StoryLearn about insights, research, case studies, and tutorials on integrating remote specimen collection, microsampling, and more!
© Neoteryx 2021 | Privacy Policy | Sitemap
421 Amapola Ave
Torrance, CA 90501
This site is protected by reCAPTCHA and the Google Privacy
Policy and Terms of Service apply.
Mitra devices are intended as a specimen collector and for the storage and transport of biological fluids. They are CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia & China, Class B in South Africa, and registered with health agencies in Canada, Thailand, and Ukraine. In the United States, Mitra devices are for Research Use Only (RUO). In some countries, Mitra devices may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.
