Summary for ARTG Entry:
Roche Diagnostics Australia Pty Limited - Cobas Ampliscreen HCV Test (Version 2) - Hepatitis C virus
nucleic acid IVD, kit, nucleic acid technique (NAT)
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 HCV Test (Version 2) - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique
48374 Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Nucleic acid analysis for the detection of HCV in human samples including cadaveric samples
The COBAS® AmpliScreen HCV Test,(v2.0) is a qualitative IVD for the direct detection of Hepatitis C
Virus in RNA in human plasma. It is intended for use as a donor screening test in plasma specimens from
living and non-heart beating individual human donors.
No Specific Conditions included on Record
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