ADVIA Centaur HBc Total (HBcT) - Hepatitis B virus core total antibody 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:
48304 - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Therapeutic indications:
The ADVIA Centaur HBc Total assay is an antigen bridging microparticle chemiluminometric immunoassay used for the detection of antibodies to hepatitis B core antigen in human serum or plasma. An in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in clinical specimens.
Authorization status:
A
Authorization date:
2015-05-28
