Project record
- Case reference
- ST-016
- Target market
- Australia
- Product class
- IVD Class 3
- Our team's work
- Submitted on behalf of clients
- Evidence basis
- Retained certificate, 2 pages
What similar projects should consider
Combination tests still need individual checks of targets, specimen types and self-test or professional-use scope.
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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Open the complete redacted certificate (PDF · 2 pages)
