The Mitra Microsampler class I medical device is for direct specimen collection of blood and 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 requirements.
Open the door for combining PK and PD assessments in the same animals with Mitra microsampling technology.
Highlights of this research include:
An introduction to the Mitra Microsampling Device and a simplified microsampling workflow
Full explanation of how this technology allows for serial sampling while greatly reducing animal usage
Details on how comparable data can be generated using dried blood, whilst conserving lab costs, and animal lives
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, Brazil & 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.