Summary for ARTG Entry:
Diagnostic Technology Pty Ltd - Inborn/inherited genetic disorder IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Diagnostic Technology Pty Ltd
Suite 45 / 7 Narabang Way,BELROSE, NSW, 2085
ARTG Start Date
Medical Device Class 3
- 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.
Luminex Molecular Diagnostic Inc
439 University Avenue
Toronto, ON, M5G 1Y8
1. Inborn/inherited genetic disorder IVDs
CT903 Inborn/inherited genetic disorder IVDs
The Luminex Cystic Fibrosis assays is used to simultaneously detect and identify a panel of mutations and
variants in the Cystic Fibrosis transmemebrane conductance regulator (CFTR) gene in human samples.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:44:01 AEDT
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