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.
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 · 2 pages)