Project record
- Case reference
- ST-022
- Target market
- Australia
- Product class
- IVD Class 3
- Our team's work
- Submitted on behalf of clients
- Evidence basis
- Retained certificate, 1 page
What similar projects should consider
Antigen and nucleic acid tests involve different technologies and performance evidence. Multiplex testing alone does not define all application requirements.
Individual products still require assessment of intended use, model scope and technical documentation. This case does not replace product-specific classification.
Related services and preparation
- TGA registration consulting and application support
- Australian Sponsor responsibilities and engagement
- Preparing similar products for Australian market entry
- Documents for your first consultation
Certificate preview
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