Test to verify the analytical sensitivity of COVID-19 Rapid Antigen Test Kits
Information
Type
Guidance
Regulated products
Medical Devices
Topics
COVID-19, Manufacturing, COVID, COVID-19 Tests
Published
June 22, 2022
Last updated
June 22, 2022
Description
This document sets out the testing requirements to verify that COVID-19 Rapid Antigen Test (RAT) kits included in the ARTG meet the analytical sensitivity requirements outlined by the World Health Organisation.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)