Multiple-viruses 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:
Becton Dickinson Pty Ltd
Class:
Class 3
Manufactured by:
Becton Dickinson and Company 7 Loveton Circle, Sparks, Maryland, 21152 United States Of America
Therapeutic area:
CT702 - Multiple-viruses IVDs
Therapeutic indications:
IVD assays for the direct qualitative detection and differentiation of multiple viral infections from, for example assays for enteric viral pathogens or for respiratory viral pathogens. The IVD assays are performed using specified specimen types, utilising real-time polymerase chain reaction for the amplification of relevant gene target DNA/RNA.
Authorization status:
A
Authorization date:
2018-11-27
