ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) - HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
21-11-2017
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Available from:
Siemens Healthcare Pty Ltd
Class:
Class 4
Manufactured by:
Siemens Healthcare Diagnostics Inc 511 Benedict Avenue, Tarrytown, NY, 10591 United States Of America
Therapeutic area:
48452 - HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Therapeutic indications:
The ADVIA Centaur HIV 1/O/2 Enhanced assay is an antigen bridging microparticle chemiluminometric immunoassay used for the detection of antibodies to the human immunodeficiency virus type 1, including subtype O, and/or type 2 in serum or plasma. An in vitro diagnostic immunoassay for the qualitative determination of antibodies to the human immunodeficiency virus type 1, including subtype O, and/or type 2 in clinical specimens.
Authorization status:
Included - IVD
