Clinical performance requirements and risk mitigation strategies for HIV tests
Information
Type
Publication
Regulated products
Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
June 21, 2022
Last updated
June 24, 2024
Description
Guidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)