Clinical Chemistry IVDs

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

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Available from:
Genesis Biotech Pty Ltd
Class:
Class 1
Authorization status:
Included - IVD (Export Only)
Authorization number:
292756

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Public Summary

Summary for ARTG Entry:

292756

Genesis Biotech Pty Ltd - Clinical Chemistry IVDs

ARTG entry for

Medical Device Included - IVD (Export Only) Class 1

Sponsor

Genesis Biotech Pty Ltd

Postal Address

PO Box 4449,Forest Lake, QLD, 4078

Australia

ARTG Start Date

14/08/2017

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

Taidoc Technology Corporation

3F & 5F no 127 Wugong 2nd Road Wugu

Township

, Taipei County,

Taiwan (Province of China)

Products

1. Clinical Chemistry IVDs

Product Type

Effective date

14/08/2017

GMDN

CT287 Clinical Chemistry IVDs

Intended purpose

Pregnancy Test for the qualitative determination of human chorionic gonadotropin (hCG) in urine. They are

intended for use as an aid in the early detection of pregnancy for self-testing.

Ovulation Test for the qualitative determination of luteinising hormone (LH) in urine. They are intended for

use as an aid in the early detection of ovulation for self-testing.

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 07:34:53 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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