Interpretive software IVDs

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

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Available from:
Roche Diagnostics Australia Pty Limited
Class:
Class 3
Authorization status:
Included - IVD
Authorization number:
289786

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Public Summary

Summary for ARTG Entry:

289786

Roche Diagnostics Australia Pty Limited - Interpretive software IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Roche Diagnostics Australia Pty Limited

Postal Address

Locked Bag 2225,North Ryde, NSW, 1670

Australia

ARTG Start Date

6/06/2017

Product category

Medical Device Class 3

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

Ariosa Diagnostics Inc

5945 Optical Court

San Jose, CA, 95138

United States Of America

Products

1. Interpretive software IVDs

Product Type

Effective date

6/06/2017

GMDN

CT910 Interpretive software IVDs

Intended purpose

An interpretative software algorithm intended to be applied to a clinical result or set of results obtained

through testing in order to identify and/or formulate additional clinical information which may then be used

to guide patient management.

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 05:53:46 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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