Immunohistology

Main information

  • Trade name:
  • Immunohistology cell marker IVDs
  • Class:
  • - IVD Class 2
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Immunohistology cell marker IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216549
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216549

Biospecifix Pty Ltd - Immunohistology cell marker IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Biospecifix Pty Ltd

Postal Address

79 Peter Street,BOX HILL NORTH, VIC, 3129

Australia

ARTG Start Date

25/10/2013

Product category

Medical Device Class 2

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

IQ Products BV

Rozenburglaan 13a

, DL Groningen, 9727

Netherlands

Products

1. Immunohistology cell marker IVDs

Product Type

Effective date

25/10/2013

GMDN

CT1056 Immunohistology cell marker IVDs

Intended purpose

IQ Products supply a range of Immunohistology cell marker IVD's intended to be used in histology and

cytology for localization of specific proteins and antigens present in cytological smears and body fluids.

They are Class 2 GMDN Code CT1056 IVD's

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 04:54:31 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