T
Thukira
HI.. there is product in which prepared blood smear is used as input for the laboratory product..,
Will the product comes under IVD ?
Please help...
Will the product comes under IVD ?
Please help...
‘in vitro diagnostic medical device’ means any 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 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:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with
potential recipients, or
— to monitor therapeutic measures
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
This Directive shall apply to electrical equipment designed for
use with a voltage rating of between 50 and 1 000 V for alternating
current and between 75 and 1 500 V for direct current