Is the Intelligent Blood Collection Management System a medical device? How many categories?

Intelligent blood collection management system is not a medical device, according to the definition of medical device: medical device means instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software.

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