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Guidance on IVDs to Detect Human Papillomaviruses

11/28/2011

Federal Register Notice: FDA is making available a guidance, Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses. It provides recommendations for studies to establish the performance characteristics of IVDs intended for detecting human papillomaviruses. To download this guidance, click here. To view this notice, click here.

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