ARTG 429994cobas HIV-1 (cobas 5800/6800/8800) - HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
ARTG ID: 429994 · 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)
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 429994
- Start Date
- December 06, 2023
- Effective Date
- December 06, 2023
- Country
- United States of America
- Address
- 1080 US Highway 202, Branchburg, New Jersey, 08876
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.
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 registered under ARTG number 429994 and 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.