Platelet factor IVDs

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

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Available from:
Werfen Australia Pty Ltd
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
324315

Public Summary

Summary for ARTG Entry:

324315

Werfen Australia Pty Ltd - Platelet factor IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Werfen Australia Pty Ltd

Postal Address

59 - 61 Dickson Avenue,ARTARMON, NSW, 2064

Australia

ARTG Start Date

2/10/2019

Product category

Medical Device Class 2

Status

Active

Approval area

Manufacturers

Name

Address

Accriva Diagnostics Inc

6260 Sequence Drive

San Diego, California, 92121

United States Of America

Products

1. Platelet factor IVDs

Product Type

Effective date

2/10/2019

GMDN

CT874 Platelet factor IVDs

Intended purpose

intended to be used in testing to provide information about platelet factor components or platelet

functionality.

Specific Conditions

© 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 02.11.2019 at 03:10:26 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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