Elecsys HIV combi PT (cobas e 411/601/602) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
08-11-2017
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Available from:
Roche Diagnostics Australia Pty Limited
Class:
Class 4
Manufactured by:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Therapeutic area:
48446 - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Therapeutic indications:
Immunoassay for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1, including group O, and HIV-2 in human serum and plasma using the Elecsys and cobas e analytical systems Immunoassay for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1, including group O, and HIV-2 in human serum and plasma using the Elecsys and cobas e analytical systems
Authorization status:
A
Authorization date:
2014-07-22
