Abbott ARCHITECT HBsAg Next Qualitative

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Class:

Class D IVD

Manufactured by:

Abbott Ireland Diagnostics Division

Therapeutic area:

Immunology

Therapeutic indications:

The HBsAg Next Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma including specimens collected post mortem (non-heart-beating) on the ARCHITECT iSystem. The HBsAg Next Qualitative assay is intended to be used as an aid in the diagnosis of Hepatitis B virus (HBV) infection and as a screening test to prevent transmission of HBV to recipients of blood, blood components, cells, tissue and organs.

Product summary:

Models: ARCHITECT HBsAg Next Qualitative Reagent Kit - 4P76-25, ARCHITECT HBsAg Next Qualitative Reagent Kit - 4P76-35, ARCHITECT HBsAg Next Qualitative Reagent Kit - 4P76-30, ARCHITECT HBsAg Next Qualitative Calibrators - 4P76-01, ARCHITECT HBsAg Next Qualitative Controls - 4P76-10

Authorization date:

2020-05-26