Abbott ARCHITECT HBsAG Qualitative II Assay and ARCHITECT HBsAg Qualitative II Confirmatory Assay (2G22 and 2G23).

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Հասանելի է:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Դաս:

Class D IVD

Պատրաստված է:

Abbott Ireland Diagnostics Division

Թերապեւտիկ տարածք:

Microbiology

Թերապեւտիկ ցուցումներ:

The ARCHITECT HBsAg Qualitative II assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma including speciments collected post-mortem (non-heart-beating). The ARCHITECT HBsAg Qualitative II assay is intended to be used as an aid in the diagnosis of HBV infection and as a screening test for donated blood and plasma to prevent transmission of HBV to recipients of blood, blood components, cells, tissues and organs. The ARCHITECT HBsAg Qualitative II 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 (non-heart-beating) by means of specific antibody neutralization. It is intended to be used for the confirmation of samples found to be repeatedly reactive by ARCHITECT HBsAg Qualitative II.

Ապրանքի ամփոփագիր:

Models: Abbott Architect HBsAg Qualitative II Reagent Kit 1x100T - 2G22-25, Abbott Architect HBsAg Qualitative II Reagent Kit (4x500T) - 2G22-30, Abbott Architect HBsAg Qualitative II Reagent Kit (1x1000T) - 2G22-35, Abbott Architect HBsAg Qualitative II Calibrator - 2G22-01, Abbott Architect HBsAg Qualitative II Control - 2G22-10, Abbott Architect HBsAg Qualitative II Confirmatory Reagent Manual Diluent - 2G23-40, Abbott Architect HBsAg Qualitative II Confirmatory Reagent Kit (100T/50 determination) - 2G23-25

Հաստատման ամսաթիվը:

2012-08-28