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Multiplex viral antigen test · ST-023

For combined respiratory virus antigen testing. The certificate lists different combinations and settings including self-testing and point-of-care use.

Project record

Case reference
ST-023
Target market
Australia
Product class
IVD Class 3
Our team's work
Submitted on behalf of clients
Evidence basis
Retained certificate, 3 pages

What similar projects should consider

An ARTG entry may list multiple product names or combinations. Check specific models and use scope.

Individual products still require assessment of intended use, model scope and technical documentation. This case does not replace product-specific classification.

Certificate preview

Grey areas conceal manufacturer and client information. The document below contains all pages with text and images redacted.

Open the complete redacted certificate (PDF · 3 pages)Multiplex viral antigen test · ST-023: redacted certificate first page

Discuss your product registration project

Provide intended use, existing authorizations and launch plans so we can assess preparation and support needs.