Seasonal Influenza IVD self-tests
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Published
March 18, 2021
Last updated
March 18, 2021
Description
Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)