Conformity assessment procedures for immunohaematology reagents

Information

Type

Guidance

Regulated products

Medical Devices

Published

June 19, 2024

Last updated

June 19, 2024

Description

This guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.

Organization

Country / Region

Australia

License

Other (Non-Commercial)

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