|Trade Name||IMMULITE & IMMULITE 2000 HBSAG ASSAY|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for replacement of the sodium based buffer with potassium phosphate buffer and addition of 2. 0% normal mouse serum and 1. 2% e-amino-n-caproic acid in reagent a, and the addition of 0. 2% sodium heparin in reagent b followed by refiltering of diluent, and is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information.