"proizvod, uporabljen za diagnostiko in vitro" pomeni pakiran proizvod, gotov in pripravljen, da ga uporabi končni uporabnik; vsebuje proizvod iz krvi in se uporablja kot reagent, reagentski proizvod, kalibrator, oprema ali kateri koli drug sistem, ne glede na to, ali se uporablja samostojno ali v povezavi z drugimi, namenjen uporabi in vitro za pregledovanje vzorcev humanega ali živalskega izvora, razen darovanih organov ali krvi, z edinim ali glavnim namenom diagnosticiranja fiziološkega stanja, zdravstvenega stanja, bolezni ali genetske abnormalnosti ali za določanje varnosti ter združljivosti z reagenti;
'product used for in vitro diagnosis' means a packaged product, ready for use by the end user, containing a blood product, and used as a reagent, reagent product, calibrator, kit or any other system, whether used alone or in combination, intended to be used in vitro for the examination of samples of human or animal origin, with the exception of donated organs or blood, solely or principally with a view to the diagnosis of a physiological state, state of health, disease or genetic abnormality or to determine safety and compatibility with reagents;