The utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purposes are the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; pregnancy control; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
Intelligent blood collection management system does not satisfy, as well as the classification situation, so it is not a medical device