In vitro diagnostic devices
An in vitro diagnostic medical device 
is any device composed of reagents, reagent products, sets, instrument, apparatuses or systems used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body in order to provide information on physiological states or on health or disease or congenital anomaly.
In vitro diagnostic medical device is considered to be:
is any device composed of reagents, reagent products, sets, instrument, apparatuses or systems used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body in order to provide information on physiological states or on health or disease or congenital anomaly.In vitro diagnostic medical device is considered to be:
- a reagent
- a reactive product
- a calibrator
- a control material
- a kit
- an instrument
- an apparatus
- equipment or system
