Bacterial infectious disease 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:
ESL Biosciences Australia 2012 Pty Ltd
Class:
Class 2
Manufactured by:
EUROIMMUN Medizinische Labordiagnostika AG Seekamp 31, Luebeck, Luebeck, 23560 Germany
Therapeutic area:
CT353 - Bacterial infectious disease IVDs
Therapeutic indications:
IVDs that are intended to be used to determine (qualitative and or quantitative) information about infection with or exposure to one or a number of bacterial diseases in a clinical specimen. Each IVD is intended to be used by a medical laboratory scientist. Techniques used include: ELISA, Indirect Immunofluorescence,immune blots or western blot
Authorization status:
A
Authorization date:
2010-10-01
