ARTG 404525Acquired genetic alteration IVDs
ARTG ID: 404525 · Bio-Strategy Pty Ltd · Veracyte Inc · Class IIb · Started February 08, 2023
Good Name: Bio-Strategy Pty Ltd - Acquired genetic alteration IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 404525
- Start Date
- February 08, 2023
- Effective Date
- February 08, 2023
- Name
- Veracyte Inc
- Country
- United States of America
- Address
- 6000 Shoreline Ct Suite 300, South San Francisco, California, 94080
The Prosigna Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic which uses the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence. The gene expression data are weighted together with clinical variables to generate both a subtype (luminal A, luminal B, Her2-enriched, or basal like) and a score indicative of the probability of distance recurrence of disease. The assay measures the gene expression profile using RNA extracted from Formalin-Fixed, Paraffin-Embedded (FFPE) breast tumor tissue. Veracyte confirm that Veracyte Inc. has the design controls for the device.
Access comprehensive regulatory information for Acquired genetic alteration IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 404525 and sponsored by Bio-Strategy Pty Ltd, manufactured by Veracyte Inc in United States of America. The device registration started on February 08, 2023.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.