| http://www.w3.org/ns/prov#value | - Rule 3: An IVDD that is intended to be used for patient management is classified as Class II, unless it falls into one of the following categories, in which case it is classified as Class III: (a) it is intended to be used for the management of patients suffering from a life-threatening disease; or (b) there is a risk that an erroneous result will lead to a patient management decision resulting in
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