|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||BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of a new filling machine for use in the manufacture of filled positive and negative control vials and calibrator vials.