Project record
- Case reference
- ST-026
- Target market
- Australia
- Product class
- IVD Class 1
- Our team's work
- Submitted on behalf of clients
- Evidence basis
- Retained certificate, 1 page
What similar projects should consider
Assess the instrument and associated reagents separately for use, compatibility and licensing scope. An instrument's class does not determine every reagent's classification.
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 · 1 page)
