Immunosuppressant

Main information

  • Trade name:
  • Immunosuppressant therapeutic drug monitoring IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Immunosuppressant therapeutic drug monitoring IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216588
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216588

Roche Diagnostics Australia Pty Limited - Immunosuppressant therapeutic drug monitoring IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Roche Diagnostics Australia Pty Limited

Postal Address

Locked Bag 2225,North Ryde, NSW, 1670

Australia

ARTG Start Date

25/10/2013

Product category

Medical Device Class 3

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

Roche Diagnostics GmbH

Sandhofer Strasse 116

Mannheim Baden-Wurttemberg, , D-68305

Germany

Products

1. Immunosuppressant therapeutic drug monitoring IVDs

Product Type

Effective date

25/10/2013

GMDN

CT866 Immunosuppressant therapeutic drug monitoring IVDs

Intended purpose

In vitro diagnostic immunoassays for the quantitative determination of immunosuppressive agents in

human whole blood. Includes quality controls and calibrators

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 10.11.2017 at 04:47:21 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