Specimen receptacle IVDs
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.
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.