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Se trata de un dispositivo IVD diseñado para su uso conensayos para el cribado, la monitorización (ayuda para lamonitorización), diagnóstico (ayuda para el diagnóstico) ypronóstico; asimismo, el dispositivo puede utilizarse pararealizar tests diagnósticos complementarios.

El desorden específico y las poblaciones de prueba estáncubiertos por los ensayos aplicables que se realizan en elinstrumento. Entre los tipos de muestra que puedenutilizarse se encuentra el suero, la orina, el líquidocefalorraquídeo, fluido oral, hemolisato y plasma, usadospara detectar y/o cuantificar los analitos cubiertos por losensayos específicos.

Los usuarios previstos de este dispositivo son técnicos delaboratorio e ingenieros de servicio de campo formadoscon la debida formación (solo uso profesional).", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" } ] } } ] }