General laboratory reagent and consumables IVDs

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

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Available from:
Hologic (Australia & New Zealand) Pty Ltd
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
293044

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Public Summary

Summary for ARTG Entry:

293044

Hologic Australia Pty Ltd - General laboratory reagent and consumables IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Hologic Australia Pty Ltd

Postal Address

PO Box 1971,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

21/08/2017

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

Hologic Inc

10210 Genetic Center Drive

San Diego, CA, 92121

United States Of America

Products

1. General laboratory reagent and consumables IVDs

Product Type

Effective date

21/08/2017

GMDN

CT946 General laboratory reagent and consumables IVDs

Intended purpose

The Panther Fusion Specimen Lysis Tube is for use with Panther Fusion assays. The Panther Fusion

Specimen Lysis Tube is intended to be used for processing of specimens.

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 06:04:40 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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