Main information

  • Trade name:
  • Parasitic infectious diseases IVDs
  • Class:
  • - IVD Class 2
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Parasitic infectious diseases IVDs
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220014
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Abacus ALS Pty Ltd - Parasitic infectious diseases IVDs

ARTG entry for

Medical Device Included - IVD Class 2


Abacus ALS Pty Ltd

Postal Address

PO Box 446,WATERFORD, QLD, 4133


ARTG Start Date


Product category

Medical Device Class 2



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.




Savyon Diagnostics Ltd

Kiryat Minrav 3 Habosem Street

, Ashdod, 7761003



1. Parasitic infectious diseases IVDs

Product Type

Effective date



CT356 Parasitic infectious diseases IVDs

Intended purpose

To provide information about the presence of, or infection with one or a number of parasitic organisms

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 05:40:44 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.

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There are no safety alerts related to this product.


Scientific guideline:  Reflection paper on resistance in ectoparasites, draft: consultation open

Scientific guideline: Reflection paper on resistance in ectoparasites, draft: consultation open

The Committee adopted a new draft reflection paper on ectoparasitic resistance (EMA/CVMP/EWP/310225/2014) for a 11-month period of public consultation. The reflection paper aims to give an overview of the currently known resistance situation in ectoparasites to active substances used in veterinary medicinal products with a special focus on Europe, and to provide a review of the current knowledge on resistance mechanisms.

Europe - EMA - European Medicines Agency