Module 19 2021

Intended Purpose and Classification

• Example 2.

Option 1. This is a PCR assay for the detection of CMV in human serum for the diagnosis of CMV infection.

Class C – Rule 3.c

Option 2. This is a PCR assay for the detection of CMV in human serumfor the diagnosis of CMV infection and in human donor organs before transplantation.

Class D – Rule 1

In Option 1, the use for testing of human donor organs may be foreseeable misuse: disclaimer to be considered

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