Clinical chemistry substrate IVDs

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

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Available from:
Douglass Hanly Moir Pathology, Barratt & Smith Pathology, SAN Pathology, Sonic Clinical Trials
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
321501

Public Summary

Summary for ARTG Entry:

321501

Douglass Hanly Moir Pathology, Barratt & Smith Pathology, SAN Pathology, Sonic Clinical Trials - Clinical

chemistry substrate IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Douglass Hanly Moir Pathology, Barratt & Smith Pathology, SAN Pathology, Sonic Clinical

Trials

Postal Address

14 Giffnock Avenue,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

8/08/2019

Product category

Medical Device Class 2

Status

Active

Approval area

Manufacturers

Name

Address

Quantimetrix Corporation

2005 Manhattan Beach Boulevard

Redondo Beach, CA, 90278

United States Of America

Products

1. Clinical chemistry substrate IVDs

Product Type

Effective date

8/08/2019

GMDN

CT833 Clinical chemistry substrate IVDs

Intended purpose

Test kits and controls used for the analysis of lipoprotein sub fractions in serum or plasma. Lipoprotein

cholesterol measurements are used as an aid in evaluation of lipid metabolism disorders when used in

conjunction with other lipid tests, patient risk assessment and clinical evaluation

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 07:32:52 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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