the microsampling blog / pediatric clinical trials

In some territories, which are listed in our website footer, our microsampling devices are supplied for therapeutic or IVD use as referenced in some of our content. Outside of those territories our devices are supplied for research use only (RUO).

studying infants & children is easier with microsampling

by Neoteryx | 2 min read

studying infants & children is easier with microsampling

Pediatric research studies are essential because they improve health and healthcare for infants and children. They allow scientists conducting pediatric studies to detect diseases early and to design better methods …

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pediatric clinical trials: microsampling gives kids a better experience

by Neoteryx | 3 min read

pediatric clinical trials: microsampling gives kids a better experience

Children often benefit from off-label use or new applications of prescription drugs, but they are not always well-represented in clinical research studies. One explanation is that children require special considerations when they …

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Mitra® devices are intended as a specimen collector and for the storage and transport of blood. They are CE-IVD 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 and Ukraine. 

In the USA, Mitra devices are supplied as a Research-Use Only (RUO) product, to assist in method development, other research-related and non-diagnostic activities. Mitra has not been validated for use with any diagnostic testing. The suitability of Mitra for any analytical application must be evaluated and validated by the laboratory or research institute in a manner consistent with local regulatory requirements. 

hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research use only (RUO) and not for therapeutic or diagnostic use. 

Mitra®, VAMS® & hemaPEN® are registered trademarks owned by Trajan Scientific Australia Pty Ltd. 

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