ARCHITECT

Main information

  • Trade name:
  • ARCHITECT Syphilis TP - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
  • Class:
  • - IVD Class 4
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ARCHITECT Syphilis TP - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222510
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222510

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

Sponsor

Abbott Australasia Pty Ltd Diagnostic Division

Postal Address

Locked Bag 2005,North Ryde, NSW, 1670

Australia

ARTG Start Date

15/04/2014

Product category

Medical Device Class 4

Status

Active

Approval area

Conditions

- 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.

Manufacturers

Name

Address

Abbott GmbH & Co KG

Max Planck Ring 2

Wiesbaden, Delkenheim, 65205

Germany

Products

1. ARCHITECT Syphilis TP - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit,

chemiluminescent immunoassay

Product Type

Effective date

15/04/2014

GMDN

59861 Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent

immunoassay

Functional description

A chemiluminescent microparticle immunoassay for the detection of antibodies to treponema pallidum

(syphilis)

Intended purpose

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

heart).

Variant information

Specific Conditions

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.

Public Summary

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

10-10-2017

The Danish Medicines Agency contributes to review of Chinese medicines act

The Danish Medicines Agency contributes to review of Chinese medicines act

On Monday 9 October, a Chinese delegation headed by Xu Jinghe visited the Danish Medicines Agency. Xu Jinghe is Director General of the CFDA's Department of Legal Affairs and one of the main architects of the renewal of the Chinese medicines legislation.

Danish Medicines Agency

10-9-2018

 Architect/Building engineer - External expert contract - EMA/CEI/2018-2

Architect/Building engineer - External expert contract - EMA/CEI/2018-2

Europe - EMA - European Medicines Agency