Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Roche Diagnostics Australia Pty Limited - cobas HBV/HCV/HIV-1 Control Kit for use on the cobas 4800
System - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ARTG entry for
Medical Device Included - IVD Class 4
Roche Diagnostics Australia Pty Limited
Locked Bag 2225,North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class 4
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim Baden-Wurttemberg, , D-68305
1. cobas HBV/HCV/HIV-1 Control Kit for use on the cobas 4800 System - HIV1/Hepatitis C virus/Hepatitis B
virus nucleic acid IVD, control
48218 HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
cobas HBV/HCV/HIV-1 Control Kit contains a Low Positive control, High Positive control and Negative
control and is to be used as a batch control for the cobas HBV, cobas HCV, and cobas HIV-1 tests for use
on the cobas 4800 System (nucleic acid technique).
cobas HBV/HCV/HIV-1 Control Kit is used for the quality control of the cobas HBV, cobas HCV, and cobas
HIV-1 tests for use on the cobas 4800 System.
No Specific Conditions included on Record
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Produced at 22.11.2017 at 09:35:38 AEDT
This is not an ARTG Certificate document.
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