Australia - English - Department of Health (Therapeutic Goods Administration)
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
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class 2
- 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
CT833 Clinical chemistry substrate IVDs
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.
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Produced at 02.11.2019 at 05:09:36 AEDT
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