Inborn inherited

Main information

  • Trade name:
  • Inborn/inherited genetic disorder IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Inborn/inherited genetic disorder IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217262
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217262

Diagnostic Technology Pty Ltd - Inborn/inherited genetic disorder IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Diagnostic Technology Pty Ltd

Postal Address

Suite 45 / 7 Narabang Way,BELROSE, NSW, 2085

Australia

ARTG Start Date

13/11/2013

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

Luminex Molecular Diagnostic Inc

439 University Avenue

Toronto, ON, M5G 1Y8

Canada

Products

1. Inborn/inherited genetic disorder IVDs

Product Type

Effective date

13/11/2013

GMDN

CT903 Inborn/inherited genetic disorder IVDs

Intended purpose

The Luminex Cystic Fibrosis assays is used to simultaneously detect and identify a panel of mutations and

variants in the Cystic Fibrosis transmemebrane conductance regulator (CFTR) gene in human samples.

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 02:44:01 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