Australia TGA ARTG record

Specimen receptacle IVDs

Australia TGA ARTG Registered Device · Roche Products Pty Ltd · Foundation Medicine Inc · Class I · Started October 16, 2023

Good Name: Roche Products Pty Ltd - Specimen receptacle IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: October 16, 2023
Effective Date: October 16, 2023

Sponsor

Name: Roche Products Pty Ltd

Manufacturer

Name: Foundation Medicine Inc
Country: United States of America
Address: 150 Second Street, Cambridge, MA, 02141

Intended purpose

The FoundationOne®Liquid CDx (F1LCDx) Specimen Collection Kit is intended to allow the collection and transport of whole blood, from the specimen collection site to the clinical laboratory, for the purpose of testing with the F1LCDx Assay. The cell-free DNA collection tube, included in the F1LCDx Specimen Collection Kit, is a direct draw whole blood collection tube intended for collection, stabilization, and transportation of whole blood specimens, and for the preservation of nucleated cells to enable analysis of cell-free DNA.

About this record

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Roche Products Pty Ltd, manufactured by Foundation Medicine Inc in United States of America. The device registration started on October 16, 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.