Australia TGA ARTG record

cobas DPX - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Australia TGA ARTG Registered Device · Roche Diagnostics Australia Pty Limited · Roche Molecular Systems Inc · Class III · Started November 24, 2023

Good Name: Roche Diagnostics Australia Pty Limited - cobas DPX - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Device classification

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

Registration information

Start Date: November 24, 2023
Effective Date: November 24, 2023

Sponsor

Name: Roche Diagnostics Australia Pty Limited

Manufacturer

Name: Roche Molecular Systems Inc
Country: United States of America
Address: 1080 US Highway 202, Branchburg, New Jersey, 08876

Intended purpose

The cobas DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (HAV) genotypes I, II, and III RNA in human plasma. This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood or for use as an aid in diagnosis for parvovirus B19 or HAV.

About this record

Access comprehensive regulatory information for cobas DPX - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT) in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Molecular Systems Inc in United States of America. The device registration started on November 24, 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.