Summary for ARTG Entry:
Werfen Australia Pty Ltd - Platelet factor IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Werfen Australia Pty Ltd
59 - 61 Dickson Avenue,ARTARMON, NSW, 2064
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.
180 Hartwell Road
Bedford, MA, 01730-2443
United States Of America
1. Platelet factor IVDs
CT874 Platelet factor IVDs
IVDs that are intended to be used in testing to provide information about platelet factor components or
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 01:32:02 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information