Fibrinolysis

Main information

  • Trade name:
  • Fibrinolysis IVDs
  • Class:
  • - IVD Class 2
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Fibrinolysis IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218700
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218700

Grifols Australia Pty Ltd - Fibrinolysis IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Grifols Australia Pty Ltd

Postal Address

Unit 5/80 Fairbank Road,CLAYTON SOUTH, VIC, 3169

Australia

ARTG Start Date

20/12/2013

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

Diagnostic Grifols SA

Passeig Fluvial 24 Parets Del Valles

Barcelona, , 08150

Spain

Products

1. Fibrinolysis IVDs

Product Type

Effective date

20/12/2013

GMDN

CT875 Fibrinolysis IVDs

Intended purpose

Qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation

products (XL-FDP) in human plasma and Latex Immunoturbidimetric Assay kit to perform a quantitative

determination of D-Dimer antigen in citrated human plasma, by means of polystyrene micro-particle

agglutination method.

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 09:37:35 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