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5 Class 1 No public health risk Low personal risk Sample collection containers Microbiological culture media Class 2 Low public health risk Moderate personal risk Pregnancy and fertility self-testing kits Cholesterol tests Class 3 Moderate public health risk High personal risk Tests to detect a sexually transmitted disease (e.g., chlamydia, gonorrhea) Human genetic tests Class 4 High public health risk HIV screening tests Ebola tests A conformity assessment involves the examination of clinical data, design records, quality processes, and technical documentation to determine if the device performs as intended and conforms to TGAs Essential Principles

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