Summary for ARTG Entry:
Elitechgroup Australia PTY LTD - Fungal infectious disease IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Elitechgroup Australia Pty Ltd
PO Box 576,BRAESIDE, VIC, 3195
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.
19 allee d'Athenes
Parc d'Activities du Plateau
, Signes, 83870
1. Fungal infectious disease IVDs
CT354 Fungal infectious disease IVDs
IVDs intended to be used in testing to provide information about infection with or exposure to various yeast
and/or fungal diseases.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:03:19 AEDT
This is not an ARTG Certificate document.
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