COVID-19 rapid antigen tests - information for manufacturers and sponsors

Information

Type

Guidance

Regulated products

Medical Devices

Topics

COVID-19, In Vitro Diagnostic Medical Devices (IVDs)

Published

February 11, 2022

Last updated

February 11, 2022

Description

Information for manufacturers and sponsors on COVID-19 rapid antigen tests (RATs) regulatory requirements and processes.

Organization

Country / Region

Australia

License

Other (Non-Commercial)

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