|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.|
|Trade Name||ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend the application of the architect hbsag/ architect hbsag confirmatory assay, currently approved for use on the abbott architect i2000/i2000sr, onto a new architect i system family member, the architect i 1000sr.