" /> In Vitro Diagnostic Device - CISMeF





Preferred Label : In Vitro Diagnostic Device;

NCIt related terms : Companion Diagnostic;

NCIt definition : A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis.;

Alternative definition : CDISC-GLOSS: A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis. (After Regulation (EU) 2017/746; After US FDA 21 CFR 809.3);

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10/07/2025


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