Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Roche Diagnostics Australia Pty Limited - Interpretive software IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Roche Diagnostics Australia Pty Limited
Locked Bag 2225,North Ryde, NSW, 1670
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.
Ariosa Diagnostics Inc
5945 Optical Court
San Jose, CA, 95138
United States Of America
1. Interpretive software IVDs
CT910 Interpretive software IVDs
An interpretative software algorithm intended to be applied to a clinical result or set of results obtained
through testing in order to identify and/or formulate additional clinical information which may then be used
to guide patient management.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 05:53:46 AEDT
This is not an ARTG Certificate document.
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