Thrombophilia

Main information

  • Trade name:
  • Thrombophilia and coagulation inhibitor IVDs
  • Class:
  • - IVD Class 2
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Thrombophilia and coagulation inhibitor IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220948
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220948

Haematex Research Pty Ltd - Thrombophilia and coagulation inhibitor IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Haematex Research Pty Ltd

Postal Address

Unit 9/17 King Road,HORNSBY, NSW, 2077

Australia

ARTG Start Date

11/03/2014

Product category

Medical Device Class 2

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

HYPHEN BioMed SAS

ZAC Neuville Universite 155 rue d'Eragny

Neuville Sur Oise, , 95000

France

HYPHEN BioMed SAS

ZAC Neuville Universite 155 rue d'Eragny

Neuville Sur Oise, , 95000

France

Products

1. Thrombophilia and coagulation inhibitor IVDs

Product Type

Effective date

11/03/2014

GMDN

CT876 Thrombophilia and coagulation inhibitor IVDs

Intended purpose

IVDs for the measurement of plasma proteins controlling thrombosis and exhibiting antithrombotic

properties.

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 02:40:43 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