Summary for ARTG Entry:
Grifols Australia Pty Ltd - Coagulation factor IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Grifols Australia Pty Ltd
Unit 5/80 Fairbank Road,CLAYTON SOUTH, VIC, 3169
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.
Diagnostic Grifols SA
Passeig Fluvial 24 Parets Del Valles
Barcelona, , 08150
1. Coagulation factor IVDs
CT877 Coagulation factor IVDs
Intended to be used for quantitative determination, of Factor V in human plasma by the one stage method
using thromboplastin reagent,of Factor VIII in human plasma by the one-stage method based on APTT
and of Fibrinogen in human plasma according to the Clauss method.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:37:51 AEDT
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