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 2
Authorization status:
Included - IVD
Authorization number:

Public Summary

Summary for ARTG Entry:


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

ARTG entry for

Medical Device Included - IVD Class 2


Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

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


ARTG Start Date


Product category

Medical Device Class 2



Approval area


- 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.




Associates Of Cape Cod Inc

124 Bernard E Saint Jean Drive

East Falmouth, Massachusetts,

United States Of America


1. Clinical chemistry substrate IVDs

Product Type

Effective date



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

Public Summary

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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.

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