Main information

  • Trade name:
  • Specimen receptacle IVDs
  • Class:
  • - IVD Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Specimen receptacle IVDs
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220968
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Edwards Group Pty Ltd - Specimen receptacle IVDs

ARTG entry for

Medical Device Included - IVD Class 1


Edwards Group Pty Ltd

Postal Address

PO Box 1294,Narellan, NSW, 2567


ARTG Start Date


Product category

Medical Device Class 1



Approval area


- 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.




Labcon North America

3700 Lakeville Highway

Petaluma, CA, 94954

United States Of America


1. Specimen receptacle IVDs

Product Type

Effective date



CT936 Specimen receptacle IVDs

Intended purpose

Intended for containing the samples or specimens intended for IVD investigations, including centrifuge.

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 02:36:08 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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