In vitro diagnostic medical device

this is:

(a) a medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer for in vitro use for the examination of samples taken from the human body, including blood and tissues, solely or mainly for the purpose of providing information:

– of physiological or pathological condition,

– with birth defects,

– to establish safety for the potential recipient and compliance with the potential recipient,

– to monitor therapeutic activities,

(b) a sample container specially designed by the manufacturer for the direct storage and protection of samples taken from the human body for in vitro diagnostic testing,

(c) general-purpose laboratory equipment where, by virtue of its characteristics, it is specifically intended by the manufacturer for use in in vitro diagnostic tests (Article 13(1)(a) and (b) of Directive 91/414/EEC; Article 2(1)(39) of the Medical Devices Act).