ARCHITECT HBsAg Next Confirmatory Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Abbott Australasia Pty Ltd Diagnostic Division

Class:

Class 4

Manufactured by:

Abbott Ireland Diagnostics Division Finisklin Business Park, SLIGO Ireland

Therapeutic area:

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

Therapeutic indications:

This assay consists of two 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 chemiluminescent microparticle immunoassays (CMIA) technology with flexible assay protocols, referred to as Chemiflex. The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma including specimens collected post mortem (nonheart- beating) up to 24 hours after death by means of specific antibody neutralization on the ARCHITECT iSystem. It is intended to be used for the confirmation of samples found to be repeatedly reactive by HBsAg Next Qualitative.

Authorization status:

A

Authorization date:

2020-05-18