Summary for ARTG Entry:
Biomerieux Australia Pty Ltd - Acquired genetic alteration IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Biomerieux Australia Pty Ltd
PO Box 897,BAULKAM HILLS, NSW, 2153
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.
376 Chemin de l'Orme
Marcy, L Etoile, 69280
1. Acquired genetic alteration IVDs
CT929 Acquired genetic alteration IVDs
IVDs intended to be used in genetic testing to provide information about acquired genetic alterations,
which may include chromosomal alterations, mutations and/or alterations in gene expression, and which
may be used to characterise haematological or solid tumour malignancies and/or provide prognostic
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:01:57 AEDT
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