Genscreen

Main information

  • Trade name:
  • Genscreen ULTRA HIV Ag-Ab - HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
  • Class:
  • - IVD Class 4
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Genscreen ULTRA HIV Ag-Ab - HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220632
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220632

Bio-Rad Laboratories Pty Ltd - Genscreen ULTRA HIV Ag-Ab - HIV1/HIV2 antigen/antibody IVD, kit,

enzyme immunoassay (EIA)

ARTG entry for

Medical Device Included - IVD Class 4

Sponsor

Bio-Rad Laboratories Pty Ltd

Postal Address

PO Box 752,GLADESVILLE, NSW, 1675

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

Bio-Rad

3 Boulevarde Raymond Poincare

, MARNES-LA-COQUETTE, 92430

France

Products

1. Genscreen ULTRA HIV Ag-Ab - HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Product Type

Effective date

1/03/2014

GMDN

48445 HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Functional description

A qualitative enzyme immunoassay kit for the detection of HIV p24

antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma.

Intended purpose

The Genscreen™ ULTRA HIV Ag-Ab is a qualitative enzyme immunoassay kit for the detection of HIV p24

antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma. This kit can be

used for both HIV Ag and HIV Ab screening

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 10.11.2017 at 03:31:48 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