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physiological of pathological state, or • concerning a congenital abnormality, or • to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures." it should be noted that there is a combination possibility as some medical devices will incorporate pharmacological substances...
to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; it should be noted that there is a combination possibility as some medical devices will incorporate pharmacological substances...