cobas HBV/HCV/HIV-1 Control Kit for use on the cobas 4800 System - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, co

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Roche Diagnostics Australia Pty Limited
Class:
Class 4
Authorization status:
Included - IVD
Authorization number:
294020

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Public Summary

Summary for ARTG Entry:

294020

Roche Diagnostics Australia Pty Limited - cobas HBV/HCV/HIV-1 Control Kit for use on the cobas 4800

System - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

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

18/09/2017

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 Diagnostics GmbH

Sandhofer Strasse 116

Mannheim Baden-Wurttemberg, , D-68305

Germany

Products

1. cobas HBV/HCV/HIV-1 Control Kit for use on the cobas 4800 System - HIV1/Hepatitis C virus/Hepatitis B

virus nucleic acid IVD, control

Product Type

Effective date

18/09/2017

GMDN

48218 HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Functional description

cobas HBV/HCV/HIV-1 Control Kit contains a Low Positive control, High Positive control and Negative

control and is to be used as a batch control for the cobas HBV, cobas HCV, and cobas HIV-1 tests for use

on the cobas 4800 System (nucleic acid technique).

Intended purpose

cobas HBV/HCV/HIV-1 Control Kit is used for the quality control of the cobas HBV, cobas HCV, and cobas

HIV-1 tests for use on the cobas 4800 System.

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

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Produced at 22.11.2017 at 09:35:38 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

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