Acquired

Main information

  • Trade name:
  • Acquired genetic alteration IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Acquired genetic alteration IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217781
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217781

Biomerieux Australia Pty Ltd - Acquired genetic alteration IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Biomerieux Australia Pty Ltd

Postal Address

PO Box 897,BAULKAM HILLS, NSW, 2153

Australia

ARTG Start Date

27/11/2013

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

Biomerieux SA

376 Chemin de l'Orme

Marcy, L Etoile, 69280

France

Products

1. Acquired genetic alteration IVDs

Product Type

Effective date

27/11/2013

GMDN

CT929 Acquired genetic alteration IVDs

Intended purpose

IVDs intended to be used in genetic testing to provide information about acquired genetic alterations,

which may include chromosomal alterations, mutations and/or alterations in gene expression, and which

may be used to characterise haematological or solid tumour malignancies and/or provide prognostic

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 10.11.2017 at 01:01:57 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

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