Immunohaematology-related IVDs

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

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Available from:
Haemokinesis Pty Ltd
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
322004

Public Summary

Summary for ARTG Entry:

322004

Haemokinesis Pty Ltd - Immunohaematology-related IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Haemokinesis Pty Ltd

Postal Address

16 Technology Circuit,HALLAM, VIC, 3803

Australia

ARTG Start Date

20/08/2019

Product category

Medical Device Class 2

Status

Active

Approval area

Manufacturers

Name

Address

Haemokinesis Pty Ltd

16 Technology Circuit

HALLAM, VIC, 3803

Australia

Products

1. Immunohaematology-related IVDs

Product Type

Effective date

20/08/2019

GMDN

CT1270 Immunohaematology-related IVDs

Intended purpose

Diluting patient/donor red cells and reagent red cells to 0.8% concentration for use on the gel card.

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 06:30:13 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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