|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||MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT|
|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 bio-rad laboratories in woodinville, washington.