Summary for ARTG Entry:
Siemens Healthcare Pty Ltd - Treponema (syphilis) IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Siemens Healthcare Pty Ltd
885 Mountain Highway,Bayswater, VIC, 3153
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.
Siemens Healthcare Diagnostics Products Ltd
Llanberis, Gwynedd, LL55 4EL
1. Treponema (syphilis) IVDs
CT799 Treponema (syphilis) IVDs
For in vitro diagnostic use in testing clinical specimens to provide information about infection with, or
exposure to, Treponema pallidum, the spirochete bacteria associated with syphilis, as an aid in the
diagnosis of syphilis.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:44:36 AEDT
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