PRISM

Main information

  • Trade name:
  • PRISM HCV - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
  • Class:
  • - IVD Class 4
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • PRISM HCV - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220634
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220634

Abbott Australasia Pty Ltd Diagnostic Division - PRISM HCV - Hepatitis C virus total antibody IVD, kit,

chemiluminescent assay

ARTG entry for

Medical Device Included - IVD Class 4

Sponsor

Abbott Australasia Pty Ltd Diagnostic Division

Postal Address

Locked Bag 2005,North Ryde, NSW, 1670

Australia

ARTG Start Date

1/03/2014

Product category

Medical Device Class 4

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

Abbott GmbH & Co KG

Max Planck Ring 2

Wiesbaden, Delkenheim, 65205

Germany

Products

1. PRISM HCV - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Product Type

Effective date

1/03/2014

GMDN

48366 Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Functional description

A chemiluminescent microparticle immunoassay for the qualitative determination of anti-HCV in clinical

specimens.

Intended purpose

A chemiluminescent microparticle immunoassay for the qualitative determination of antibodies to Hepatitis

C virus(anti-HCV) in clinical specimens.

Variant information

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 23.11.2017 at 03:47:04 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