Need help. A chemical supplier for a medical diagnostics company (Class I medical devices) received ISO 13485 certification with the scope of development, manufacture and marketing a certain product group for diagnostics, i.e., critical biotech. reagent, e.g., enzyme. Is the reagent, e.g. enzyme, a "medical device" or just a "product" by definition within the framework of the ISO 13485 quality management system??? within the framework of FDA QSR? within the framework of EU IVDD?