Summary for ARTG Entry:
Abbott Australasia Pty Ltd Diagnostic Division - ARCHITECT Syphilis TP - Treponema pallidum
immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
ARTG entry for
Medical Device Included - IVD Class 4
Abbott Australasia Pty Ltd Diagnostic Division
Locked Bag 2005,North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class 4
- 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 GmbH & Co KG
Max Planck Ring 2
Wiesbaden, Delkenheim, 65205
1. ARCHITECT Syphilis TP - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit,
59861 Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent
A chemiluminescent microparticle immunoassay for the detection of antibodies to treponema pallidum
A chemiluminescent microparticle immunoassay(CMIA) for the detection of antibodies to Treponema
Pallidum (Syphilis)in human clinical specimens, including specimens collected post-mortem (non-beating
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 23.11.2017 at 08:15:34 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