In Vitro Diagnostic Device

**Semantic type:** Medical Device

**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.

**Synonyms:** - Companion Diagnostic - in vitro diagnostic device