Elecsys HBsAg II Auto Confirm - Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Roche Diagnostics Australia Pty Limited

Klass:

Class 4

Tillverkad av:

Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany

Terapiområde:

60812 - Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Terapeutiska indikationer:

The Elecsys HBsAg II Auto Confirm assay is a fully automated confirmatory assay, based on the principle of specific antibody neutralization, intended to be used for samples repeatedly reactive in the Elecsys HBsAg II assay. Polyclonal HBsAg specific antibodies bind to the immunodominant epitopes of HBsAg and thereby block the binding sites for the antibodies used in the Elecsys HBsAg II assay. Immunoassay and control for in vitro confirmation of the presence of hepatitis B surface antigen in human serum and plasma samples repeatedly reactive when tested with the Elecsys HBsAg II assay. These electrochemiluminescence immunoassays (ECLIA) are intended for use on cobas e immunoassay analysers.

Bemyndigande status:

A

Tillstånd datum:

2022-06-07