Alinity i HBsAg Next Confirmatory Assay - Hepatitis B virus surface antigen 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 Ireland Diagnostics Division Finisklin Business Park, SLIGO Ireland

Terapeutisk område:

48321 - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Terapeutiske indikationer:

This assay consists of 2 single tests (HBsAgNx C1, also referred to as C1 and HBsAgNx C2, also referred to as C2) that are both one-step pre-treatment immunoassays for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma, using CMIA technology. The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) used for the confirmation of the presence of Hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heartbeating),that have been collected up to 24 hours after death, by means of specific antibody neutralization on the Alinity i system.

Autorisation status:

A

Autorisation dato:

2021-09-23