Summary for ARTG Entry:
Roche Diagnostics Australia Pty Limited - Immunosuppressant therapeutic drug monitoring IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Roche Diagnostics Australia Pty Limited
Locked Bag 2225,North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class 3
- 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. Immunosuppressant therapeutic drug monitoring IVDs
CT866 Immunosuppressant therapeutic drug monitoring IVDs
In vitro diagnostic immunoassays for the quantitative determination of immunosuppressive agents in
human whole blood. Includes quality controls and calibrators
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:47:21 AEDT
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