Fungal

Main information

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

Documents

Localization

  • Available in:
  • Fungal infectious disease IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216876
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216876

Elitechgroup Australia PTY LTD - Fungal infectious disease IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Elitechgroup Australia Pty Ltd

Postal Address

PO Box 576,BRAESIDE, VIC, 3195

Australia

ARTG Start Date

4/11/2013

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

EliTech Microbio

19 allee d'Athenes

Parc d'Activities du Plateau

, Signes, 83870

France

Products

1. Fungal infectious disease IVDs

Product Type

Effective date

4/11/2013

GMDN

CT354 Fungal infectious disease IVDs

Intended purpose

IVDs intended to be used in testing to provide information about infection with or exposure to various yeast

and/or fungal diseases.

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 04:03:19 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

13-3-2019

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Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

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Pest categorisation of Gymnosporangium spp. (non‐EU)

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20-12-2018

Pest categorisation of Cronartium spp. (non‐EU)

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Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

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13-12-2018

Pest categorisation of Septoria malagutii

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18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

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Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

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17-10-2018

Pest categorisation of Stagonosporopsis andigena

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16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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28-9-2018

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FDA - U.S. Food and Drug Administration

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"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

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Europe - EMA - European Medicines Agency