|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for introduction of a new instrument model, the immulite 2000 xpi analyzer, as a new family member of the currently approved immulite 2000 analyzer, to be used with the currently approved immulite 2000 hbsag assay. The device, as modified, will be marketed under the trade name immulite 2000 hbsag assay an 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.