Clinical chemistry substrate IVDs

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

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class 2
Authorization status:
Included - IVD
Authorization number:
322677

Public Summary

Summary for ARTG Entry:

322677

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Clinical chemistry substrate IVDs

ARTG entry for

Medical Device Included - IVD Class 2

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

4/09/2019

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

Associates Of Cape Cod Inc

124 Bernard E Saint Jean Drive

East Falmouth, Massachusetts,

United States Of America

Products

1. Clinical chemistry substrate IVDs

Product Type

Effective date

4/09/2019

GMDN

CT833 Clinical chemistry substrate IVDs

Intended purpose

The Fungitell assay is a protease zymogen-based colorimetric assay for the qualitative detection of

(1-3)-beta-D-glucan in the serum of patients with symptoms of, or medical conditions predisposing the

patient to, invasive fungal infection. The serum concentration of (1-3)-beta-D-glucan, a major cell-wall

component of various medically important fungi, can be used as an aid in the diagnosis of deep-seated

mycoses and fungemias. A positive result does not indicate which genus of fungi may be causing infection.

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 05:09:36 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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