Australia TGA ARTG recordcobas HIV-1/HIV-2 Qualitative (cobas 5800/6800/8800) - HIV1/HIV2 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 20, 2023
Good Name: Roche Diagnostics Australia Pty Limited - cobas HIV-1/HIV-2 Qualitative (cobas 5800/6800/8800) - HIV1/HIV2 nucleic acid IVD, kit, nucleic acid technique (NAT)
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- December 20, 2023
- Effective Date
- December 20, 2023
- Country
- United States of America
- Address
- 1080 US Highway 202, Branchburg, New Jersey, 08876
Nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus (HIV) type 1 (HIV-1) and type 2 (HIV-2) in human serum and plasma. The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 and may also be used to confirm HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The test is intended to be used by laboratory professionals.
Access comprehensive regulatory information for cobas HIV-1/HIV-2 Qualitative (cobas 5800/6800/8800) - HIV1/HIV2 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 20, 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.