Cobas

Main information

  • Trade name:
  • Cobas Ampliscreen HBV test - Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Class:
  • - IVD Class 4
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cobas Ampliscreen HBV test - Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219509
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219509

Roche Diagnostics Australia Pty Limited - Cobas Ampliscreen HBV test - Hepatitis B virus core nucleic acid

IVD, kit, nucleic acid technique (NAT)

ARTG entry for

Medical Device Included - IVD Class 4

Sponsor

Roche Diagnostics Australia Pty Limited

Postal Address

Locked Bag 2225,North Ryde, NSW, 1670

Australia

ARTG Start Date

23/01/2014

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

Roche Molecular Systems Inc

1080 US Highway 202

Branchburg, New Jersey, 08876

United States Of America

Products

1. Cobas Ampliscreen HBV test - Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)

Product Type

Effective date

23/01/2014

GMDN

48307 Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)

Functional description

Nucleic acid analysis for the detection of HBV in human samples including cadaveric samples

Intended purpose

The COBAS® AmpliScreen HBV Test is a qualitative IVD for the direct detection of HBV DNA in human

plasma. It is intended for use as a donor screening test in plasma specimens from living and non-heart

beating individual human donors.

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 22.11.2017 at 11:35:06 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