ARTG 413911cobas HBV/HCV/HIV-1 Control Kit (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ARTG ID: 413911 · Roche Diagnostics Australia Pty Limited · Roche Molecular Systems Inc · Class III · Started July 21, 2023
Good Name: Roche Diagnostics Australia Pty Limited - cobas HBV/HCV/HIV-1 Control Kit (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 413911
- Start Date
- July 21, 2023
- Effective Date
- July 21, 2023
- Country
- United States of America
- Address
- 1080 US Highway 202, Branchburg, New Jersey, 08876
cobas HBV/HCV/HIV-1 Control Kit is used for the quality control of the cobas HBV, cobas HCV, and cobas HIV-1 tests.
Access comprehensive regulatory information for cobas HBV/HCV/HIV-1 Control Kit (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 413911 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Molecular Systems Inc in United States of America. The device registration started on July 21, 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.