Prostate specific marker IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
14-11-2017
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Available from:
Siemens Healthcare Pty Ltd
Class:
Class 3
Manufactured by:
Siemens Healthcare Diagnostics Products Ltd Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL United Kingdom
Therapeutic area:
CT846 - Prostate specific marker IVDs
Therapeutic indications:
For in vitro diagnostic use in the quantitative and/or qualitative determination of prostate specific markers in a clinical specimen. These measurements are used in conjunction with other diagnostic procedures to aid in patient management.
Authorization status:
A
Authorization date:
2011-03-08
