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:
  • 217628
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217628

Mindray Medical Australia Pty Ltd - Haematology full blood count IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Mindray Medical Australia Pty Ltd

Postal Address

19 Harker Street,BURWOOD, VIC, 3125

Australia

ARTG Start Date

21/11/2013

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

Shenzhen Mindray Bio Medical Electronics Co

Mindray Building Keji 12th Road South Hi-Tech

Industrial Park

Nanshan, Shenzhen, 518057

China

Products

1. Haematology full blood count IVDs

Product Type

Effective date

21/11/2013

GMDN

CT878 Haematology full blood count IVDs

Intended purpose

A collection of reagents and other associated materials intended to be used for the qualitative and/or

quantitative determination of one or multiple whole blood cell parameters[also known as complete blood

count(CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test

components may include white cell count and differential, haemoglobin determination, red cell count, red

cell characterization and calculation of red cell parameters, and/or platelet count.

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 01:39:00 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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