Clinical chemistry hormone IVDs

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

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Available from:
Compliance Management Solutions
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
323989

Public Summary

Summary for ARTG Entry:

323989

Compliance Management Solutions - Clinical chemistry hormone IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Compliance Management Solutions

Postal Address

109 Ridgemont Drive,Berwick, VIC, 3806

Australia

ARTG Start Date

24/09/2019

Product category

Medical Device Class 2

Status

Active

Approval area

Manufacturers

Name

Address

Hangzhou Alltest Biotech Co Ltd

550# Yinhai Street Hangzhou Economic &

Technological Development Area

, Hangzhou, 310018

China

Products

1. Clinical chemistry hormone IVDs

Product Type

Effective date

24/09/2019

GMDN

CT850 Clinical chemistry hormone IVDs

Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of clinical chemistry

hormones in a clinical specimen. For laboratory use only.

Specific Conditions

© 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 02.11.2019 at 03:52:59 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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