Cytomegalovirus

Main information

  • Trade name:
  • Cytomegalovirus (Human herpesvirus 5) IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cytomegalovirus (Human herpesvirus 5) IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220080
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220080

Vela Diagnostics Australia Pty Ltd - Cytomegalovirus (Human herpesvirus 5) IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Vela Diagnostics Australia Pty Ltd

Postal Address

Level 9 Avaya House 123 Epping Road,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

12/02/2014

Product category

Medical Device Class 3

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

Vela Operations Singapore Pte Ltd

2-4/5/6 The Kendall 50 Science Park Road

Science Park II, , 117406

Singapore

Products

1. Cytomegalovirus (Human herpesvirus 5) IVDs

Product Type

Effective date

12/02/2014

GMDN

CT748 Cytomegalovirus (Human herpesvirus 5) IVDs

Intended purpose

For in vitro diagnostic use in the detection and quantitation of Cytomegalovirus (Human herpesvirus 5).

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 05:24:44 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.

Visit www.tga.gov.au for contact information