Fungal 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:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class 2
Manufactured by:
Meridian Bioscience INC 3471 River Hills Drive, Cincinnati, OH, 45244 United States Of America
Therapeutic area:
CT354 - Fungal infectious disease IVDs
Therapeutic indications:
Qualitative in vitro diagnostic tests that provide information about infection with or exposure to a number of yeast and/or fungal diseases. These devices are intended for use in hospital, reference or state laboratory settings. These devices are not intended for point of care use.
Authorization status:
A
Authorization date:
2013-09-16
