Application of the Rules - Flow Diagram Part 4
"Other Uses" not for transmissible diseases
Rule 4 continued
An IVDD used for diagnosis or patient management is classified as Class II unless they are used for the following, then they are Class III:
- It is used for disease staging;
- It is used to monitor levels of drugs, substances, biological components where an erroneous result would lead to a patient management decision resulting in imminent life threatening situation for the patient.
An IVDD intended to be used for blood grouping or tissue typing is Class III.
An IVDD is a Class I if:
- It is not used for diagnosis or patient management for diseases not caused by transmissible agent;
- It is not intended to be used for blood grouping or tissue typing;
- It is not used with regard to transmissible agents;
- If it is listed in the table of Rule 9.
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