Human leukocyte antigen DQ (HLA-DQ) typing sera IVDs

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

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Available from:
Bio-Strategy Pty Ltd
Class:
Class 3
Authorization status:
Included - IVD
Authorization number:
291755

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Public Summary

Summary for ARTG Entry:

291755

Bio-Strategy Pty Ltd - Human leukocyte antigen DQ (HLA-DQ) typing sera IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Bio-Strategy Pty Ltd

Postal Address

PO Box 14,CAMPBELLFIELD, VIC, 3061

Australia

ARTG Start Date

20/07/2017

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

One Lambda Inc

21001 Kittridge Street

Canoga Park, CA, 91303

United States Of America

Products

1. Human leukocyte antigen DQ (HLA-DQ) typing sera IVDs

Product Type

Effective date

20/07/2017

GMDN

CT897 Human leukocyte antigen DQ (HLA-DQ) typing sera IVDs

Intended purpose

Molecular typing kits that are intended to be used in tissue typing to determine specificity of antigens to the

human leukocyte antigen DQ (HLA-DQ) locus.

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 11:26:54 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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