Clinical chemistry hormone IVDs

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

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Available from:
Schiffa Health Pty Ltd
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
291019

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Public Summary

Summary for ARTG Entry:

291019

Schiffa Health Pty Ltd - Clinical chemistry hormone IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Schiffa Health Pty Ltd

Postal Address

PO Box 6519,Silverwater, NSW, 2128

Australia

ARTG Start Date

5/07/2017

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

Nantong Egens Biotechnology Co Ltd

Block A No15 Building No1692 Xinghu Ave

Nantong Economy & Tech Development Zone

, , 226010

China

Products

1. Clinical chemistry hormone IVDs

Product Type

Effective date

5/07/2017

GMDN

CT850 Clinical chemistry hormone IVDs

Intended purpose

Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of Chorionic

Gonadotropin (hCG) in urine samples to aid the early detection of pregnancy by professional users.

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 02:03:09 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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