|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|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the monolisa anti-hbs eia package insert in order to add the statement that allows storage of the working conjugate solution at room temperature for 30 hours, with up to 10 cycles of 3 hours at room temperature allowed.