Viral infectious disease IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
10-11-2017
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Available from:
Werfen Australia Pty Ltd
Class:
Class 2
Manufactured by:
Biokit SA Av Can Montcau 7 Llica d'Amunt, Barcelona, 08186 Spain
Therapeutic area:
CT355 - Viral infectious disease IVDs
Therapeutic indications:
IVDs that are intended to be used in testing to provide information about infection with or exposure to Epstein-Barr virus (EBV), also referred to as Human herpesvirus 4.
Authorization status:
A
Authorization date:
2013-11-13
