|Trade Name||ARCHITECT HBSAG/CONFIMATORY|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at flextronics manufacturing (s) pte ltd. In singapore for the manufacturing of the architect i2000sr processing module and the robotic sample handler.