Multiple

Main information

  • Trade name:
  • Multiple human leukocyte antigen (HLA) antibodies IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Multiple human leukocyte antigen (HLA) antibodies IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217870
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217870

Diagnostic Solutions Pty Ltd - Multiple human leukocyte antigen (HLA) antibodies IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Diagnostic Solutions Pty Ltd

Postal Address

PO Box 248,FAIRFIELD, VIC, 3078

Australia

ARTG Start Date

29/11/2013

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

Immucor GTI Diagnostics Inc

20925 Crossroads Circle

Waukesha, WI, 53186

United States Of America

Products

1. Multiple human leukocyte antigen (HLA) antibodies IVDs

Product Type

Effective date

29/11/2013

GMDN

CT1038 Multiple human leukocyte antigen (HLA) antibodies IVDs

Intended purpose

Immucor Transplant IVD kits and reagents are IVDs intended to provide tissue typing information about

antibodies directed against human leukocyte antigens (HLA) from multiple loci.

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 10.11.2017 at 12:43:34 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

20-11-2018

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20-11-2018

Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine

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9-10-2018

Notice of call for expressions of interest - Multiplex serologie

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28-9-2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

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FDA - U.S. Food and Drug Administration

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

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Health Canada

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

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FDA - U.S. Food and Drug Administration

2-8-2018

Orphan designation:  Pomalidomide,  for the: Treatment of multiple myeloma

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18-7-2018

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Orphan designation: Thalidomide, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

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At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

29-5-2018

Orphan designation:  Panobinostat,  for the: Treatment of multiple myeloma

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Europe - EMA - European Medicines Agency

29-5-2018

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Europe - EMA - European Medicines Agency

11-5-2018

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FDA - U.S. Food and Drug Administration

27-6-2011

Danish Pharmacovigilance Update, 16 June 2011

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Among the articles in this issue of Danish Pharmacovigilance Update, you can read about the removal of contraindication for Velcade® (bortezomib) used for the treatment of multiple myeloma.

Danish Medicines Agency

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

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6-8-2018

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Europe - EMA - European Medicines Agency