Summary for ARTG Entry:
Abbott Australiasia Pty Ltd (Molecular Division) - Hepatitis B virus IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Abbott Australasia Pty Ltd Molecular Division
Locked Bag 2005,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.
Abbott Molecular Inc
1300 East Touhy Avenue
Des Plaines, Illinois, 60018
United States Of America
1. Hepatitis B virus IVDs
CT704 Hepatitis B virus IVDs
This assay is intended to monitor or manage Hepatitis B virus levels in clinical samples.
No Specific Conditions included on Record
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Produced at 22.11.2017 at 11:34:50 AEDT
This is not an ARTG Certificate document.
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