It should be made clear that all tests that provide information on the predisposition to a medical condition or a disease, such as genetic tests, and tests that provide information to predict treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices.
Ba cheart a shoiléiriú gur feistí leighis diagnóiseacha in vitro iad na tástálacha uile a sholáthraíonn faisnéis ar an togracht chun reachta sláinte nó chun galair, amhail tástálacha géiniteacha, agus na tástálacha a sholáthraíonn faisnéis chun freagairt ar chóireáil nó frithghníomhartha i gcoinne cóireála a thuar, amhail feistí diagnóiseacha coimhdeachta.