Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Abbott Australasia Pty Ltd Diagnostic Division - Haematology full blood count IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Abbott Australasia Pty Ltd Diagnostic Division
Locked Bag 2005,North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class 2
- 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 Ireland Diagnostic Division
Finisklin Business Park
1. Haematology full blood count IVDs
CT878 Haematology full blood count IVDs
Reagents to be used for the qualitative and/or quantitative haematological determination of measured
and/or calculated whole blood cell parameters
No Specific Conditions included on Record
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Produced at 03.11.2017 at 03:27:13 AEDT
This is not an ARTG Certificate document.
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