ADVIA Centaur HBsAg Confirmatory (Conf) assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
22-11-2017
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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:
48321 - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Therapeutic indications:
The ADVIA Centaur HBsAg Confirmatory assay uses the principle of specific antibody neutralization to confirm the presence of HBsAg in a sample that is repeatedly reactive for HBsAg. An in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in clinical specimens.
Authorization status:
A
Authorization date:
2015-05-27
