Application of the Rules - Flow Diagram Part 1
Rules 6 and 9
A Near Patient IVDD listed in Rule 9 is a Class II IVDD.
Otherwise, a Near Patient IVDD is Class III unless:
- it detects HIV, HTLV, HBV, HCV or HDV where it is a Class IV.
When one IVDD is intended to work with another, each IVDD will be classified, but the higher risk classification will apply to both.
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