Haematology

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217627
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217627

Mindray Medical Australia Pty Ltd - Haematology calibrator/control 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 calibrator/control IVDs

Product Type

Effective date

21/11/2013

GMDN

CT879 Haematology calibrator/control IVDs

Intended purpose

A material which is used to establish known points of reference for an assay intended to be used for the

qualitative and/or quantitative determination of one or multiple whole blood cell parameters 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 10.11.2017 at 01:39:15 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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