Immunohaematology

Main information

  • Trade name:
  • Immunohaematology calibrator/control IVDs
  • Class:
  • - IVD Class 2
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Immunohaematology calibrator/control IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218234
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218234

Haemokinesis Pty Ltd - Immunohaematology calibrator/control IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Haemokinesis Pty Ltd

Postal Address

16 Technology Circuit,HALLAM, VIC, 3803

Australia

ARTG Start Date

6/12/2013

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

Alba Bioscience

Ellen's Glen Road

Edinburgh, , EH177QT

Products

1. Immunohaematology calibrator/control IVDs

Product Type

Effective date

6/12/2013

GMDN

CT890 Immunohaematology calibrator/control IVDs

Intended purpose

IVDs that are intended to be used in testing to establish known points of reference and/or verify the

perfomance of immunohaematological tests.

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 11:19:44 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