Histology

Main information

  • Trade name:
  • Histology & Cytology IVDs
  • Class:
  • - IVD (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Histology & Cytology IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222571
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222571

Becton Dickinson Pty Ltd - Histology & Cytology IVDs

ARTG entry for

Medical Device Included - IVD (Export Only) Class 1

Sponsor

Becton Dickinson Pty Ltd

Postal Address

Locked Bag 3200,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

16/04/2014

Product category

Medical Device Class 1

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

Becton Dickinson and Company

2350 Qume Drive

San Jose, California, 95131

United States Of America

Products

1. Histology & Cytology IVDs

Product Type

Effective date

16/04/2014

GMDN

CT901 Histology & Cytology IVDs

Intended purpose

The BD FACSPresto Near-Patient CD4 Counter is an automated system for in vitro diagnostic use in

performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and

hemoglobin concentration in human whole blood.

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 09.11.2017 at 09:01:35 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

There are no safety alerts related to this product.

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency