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cobas HBV/HCV/HIV-1 Control Kit (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control - ARTG 413911

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.

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TGA ARTG Official Data
Class III
ARTG 413911
Class III
cobas HBV/HCV/HIV-1 Control Kit (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ARTG ID: 413911
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
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Intended Purpose

cobas HBV/HCV/HIV-1 Control Kit is used for the quality control of the cobas HBV, cobas HCV, and cobas HIV-1 tests.

Device Classification
Risk Class
Class III
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
413911
Start Date
July 21, 2023
Effective Date
July 21, 2023
Manufacturer
Country
United States of America
Address
1080 US Highway 202, Branchburg, New Jersey, 08876