Haematology

Main information

  • Trade name:
  • Haematology full blood count IVDs
  • Class:
  • - IVD Class 2
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Haematology full blood count IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222568
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222568

Radiometer Pacific Pty Ltd - Haematology full blood count IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Radiometer Pacific Pty Ltd

Postal Address

PO Box 5134,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

16/04/2014

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

Hemocue AB

Kuvettgatan 1

, Angelholm, 26271

Sweden

Products

1. Haematology full blood count IVDs

Product Type

Effective date

16/04/2014

GMDN

CT878 Haematology full blood count IVDs

Intended purpose

HemoCue WBC and WBC DIFF Microcuvettes are to be used in conjunction with the specified HemoCue

Analyser. The two combined are an IVD intended for the quantitative determination of White cells in a

clinical specimen.

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 09.11.2017 at 09:02:22 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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