Australia TGA ARTG record

cobas HIV-1 (cobas 5800/6800/8800) - HIV1 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 December 06, 2023

Good Name: Roche Diagnostics Australia Pty Limited - cobas HIV-1 (cobas 5800/6800/8800) - HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

Device classification

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

Registration information

Start Date: December 06, 2023
Effective Date: December 06, 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

cobas HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1-infected individuals. It is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1-infected patients. This test can be used for confirmation of HIV-1 infection in antibody reactive individuals and to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment.

About this record

Access comprehensive regulatory information for cobas HIV-1 (cobas 5800/6800/8800) - HIV1 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 December 06, 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.