Devices that are used with a view to monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be companion diagnostics.
Feistí a úsáidtear chun faireachán a dhéanamh ar chóir leighis le táirge íocshláinte lena áirithiú go bhfuil tiúchan na substaintí ábhartha i gcorp an duine laistigh den teorainn teiripe, ní mheastar gur feistí diagnóiseacha coimhdeachta iad.