Alinity i Anti-HBc IgM Assay - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Abbott Australasia Pty Ltd Diagnostic Division

Klasse:

Class 4

Fremstillet af:

Abbott GmbH Max Planck Ring 2, WIESBADEN, 65205 Germany

Terapeutisk område:

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

Terapeutiske indikationer:

The Alinity i Anti-HBc IgM assay utilizes acridinium-labeled recombinant hepatitis B virus core antigen (rHBcAg) conjugate for the detection of anti-HBc IgM. The Alinity i Anti-HBc IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma on the Alinity i analyzer. The Alinity i Anti-HBc IgM assay is indicated for use as an aid in the diagnosis of acute or recent hepatitis B viral infection.

Autorisation status:

A

Autorisation dato:

2018-06-08