Summary for ARTG Entry:
Roche Diagnostics Australia Pty Limited - Cobas Ampliscreen Multiprep Specimen Preparation and Control
kit - Nucleic acid extraction/isolation IVD, kit
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 Molecular Systems Inc
1080 US Highway 202
Branchburg, New Jersey, 08876
United States Of America
1. Cobas Ampliscreen Multiprep Specimen Preparation and Control kit - Nucleic acid extraction/isolation IVD,
52521 Nucleic acid extraction/isolation IVD, kit
Sample preparation reagents and quality controls for sample analysis using the cobas Ampliscreen assays
An IVD test kit containing all required reagents for sample preparation and quality controls for sample
analysis using the cobas Ampliscreen assays
No Specific Conditions included on Record
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Produced at 10.11.2017 at 06:54:22 AEDT
This is not an ARTG Certificate document.
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