Elecsys Anti-HBc IgM (cobas e411/601/602) ) - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Roche Diagnostics Australia Pty Limited

Class:

Class 4

Manufactured by:

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

Therapeutic area:

48298 - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Therapeutic indications:

??Capture test principle immunoassay: Total duration of assay: 18 minutes. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. Immunoassay and dedicated quality control for the in vitro qualitative determination of IgM antibodies to the hepatitis B core antigen in human serum and plasma. This electrochemiluminescence (ECLIA) assay is intended for use on Elecsys and cobas immunoassay analysers.

Authorization status:

A

Authorization date:

2013-09-13