Clinical chemistry toxicology/drug detection IVDs

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

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Available from:
Beckman Coulter Australia Pty Ltd
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
292521

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Public Summary

Summary for ARTG Entry:

292521

Beckman Coulter Australia Pty Ltd - Clinical chemistry toxicology/drug detection IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Beckman Coulter Australia Pty Ltd

Postal Address

PO Box 218,GLADESVILLE, NSW, 1675

Australia

ARTG Start Date

7/08/2017

Product category

Medical Device Class 2

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

Siemens Healthcare Diagnostics Inc

500 GBC Drive Mailstop 514

Newark, DE, 19714

United States Of America

Products

1. Clinical chemistry toxicology/drug detection IVDs

Product Type

Effective date

7/08/2017

GMDN

CT184 Clinical chemistry toxicology/drug detection IVDs

Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of toxic substances,

pharmaceutical drugs and/or drugs of abuse in a clinical specimen

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 03.11.2017 at 08:38:36 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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