by Neoteryx | 4 min read
Why go to the lab or blood draw clinic if you don't have to? Many health and wellness companies now offer home health kits that enable you to collect your …
Read Storyby Neoteryx | 2 min read
The world population is expected to grow to 9 billion people by 2050. This means that food production needs to increase proportionately, by at least 60%, to feed an increased …
Read StoryLearn about insights, research, case studies, and tutorials on integrating remote specimen collection, microsampling, and more!
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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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