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:
  • 220969
  • 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.




Puritan Medical Products Company LLC

31 School Street

Guilford, Maine, 04443-0149

United States Of America


1. Specimen receptacle IVDs

Product Type

Effective date



CT936 Specimen receptacle IVDs

Intended purpose

Transport tube with swab, with or without culture media intended for collection, containment, preservation

and transport of clinical specimens or samples for analysis.

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 02:35:51 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


Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

There are no news related to this product.