Glossary Term
In Vitro Diagnostic Device
Regulatory DefinitionsEN
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.
Extended Notes
Source: National Cancer Institute, NCI Thesaurus 26.09d, C209465. NCI definition, reproduced without modification under CC BY 4.0. Source identity and definition checked automatically on 2026-10-18. No individual clinical interpretation or human reviewer is asserted.
Also Known As
In Vitro Diagnostic Device