Summary for ARTG Entry:
Beckman Coulter Australia Pty Ltd - Fibrinolysis IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Beckman Coulter Australia Pty Ltd
PO Box 218,GLADESVILLE, NSW, 1675
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.
Beckman Coulter Ireland Inc
Lismeehan O'Callaghan's Mills Co Clare
1. Fibrinolysis IVDs
CT875 Fibrinolysis IVDs
IVDs that are intended to be used in testing to provide information about fibrinolysis, fibrin degradation
products and components involved in the process of clot breakdown.
No Specific Conditions included on Record
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Produced at 18.10.2017 at 01:55:02 AEDT
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