Bordetella IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
26-05-2019
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Available from:
Hologic (Australia & New Zealand) Pty Ltd
Class:
Class 3
Manufactured by:
Diagenode sa Liege Science Park Rue Bois Saint-Jean 3, Seraing, 4102 Belgium
Therapeutic area:
CT778 - Bordetella IVDs
Therapeutic indications:
The Panther Fusion Bordetella assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Bordetella pertussis (Bp) and Bordetella parapertussis (Bpp). This assay is intended to aid in the differential diagnosis of Bordetella pertussis and Bordetella parapertussis infections in humans.
Authorization status:
A
Authorization date:
2019-04-16
