Creatine kinase IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
06-11-2017
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Available from:
Ortho-Clinical Diagnostics Australia Pty Ltd
Class:
Class 3
Manufactured by:
Ortho-Clinical Diagnostics Felindre Meadows, Pencoed Bridgend CF35 5PZ United Kingdom
Therapeutic area:
CT831 - Creatine kinase IVDs
Therapeutic indications:
IVDs that are intended to be used for the qualitative and/or quantitative determination of creatine kinase enzyme and its various forms in a clinical specimen.
Authorization status:
A
Authorization date:
2015-07-16
