7 resultaten gevonden voor 'IVD medical device'

IVD medical device

device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles

medical device

instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,

investigation, replacement, modification or support of the anatomy or of a physiological process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

providing information for medical purposes by means of in vitro examination of specimens derived from the human body,

and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which can be assisted in its intended function by such means

in vitro diagnostic medical device

device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles

IVD reagent

chemical, biological or immunological components, solutions or preparations intended by the manufacturer to be used as an IVD medical device

IVD instrument

equipment or apparatus intended by a manufacturer to be used as an IVD medical device

specimen collection device

apparatus specifically intended by an IVD manufacturer to obtain, contain and preserve a body fluid or tissue for in vitro diagnostic examination

primary sample collection device

apparatus specifically intended by an IVD manufacturer to obtain, contain and preserve a body fluid or tissue for in vitro diagnostic examination