Instrument/ analyser IVDs

Main information

  • Trade name:
  • Instrument/ analyser IVDs
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Instrument/analyser IVDs
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Included - IVD
  • Authorization number:
  • 221888
  • Last update:
  • 03-06-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221888

In Vitro Technologies Pty Ltd - Instrument/analyser IVDs

ARTG entry for

Medical Device Included - IVD Class 1

Sponsor

In Vitro Technologies Pty Ltd

Postal Address

7-9 Summit Road,NOBLE PARK, VIC, 3174

Australia

ARTG Start Date

1/04/2014

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

Boditech Med Inc

43 Geodudanji 1-gil

Dongnae-myeon

Chuncheon-si, Gang-won-do, 200-883

Korea - Republic of

Products

1. Instrument/analyser IVDs

Product Type

Effective date

1/04/2014

GMDN

CT943 Instrument/analyser IVDs

Intended purpose

Instruments used to quantify the concentration of various types of analytes, such as total hemoglobin, in

blood or urine. They can be used in a central laboratory or in a point-of-care testing facility.

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 11:23:38 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