|Trade Name||BIO-RAD MONOLISA ANTI-HBC IGM EIA|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||BIO-RAD LABORATORIES, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an amendment to the package insert with the addition of the statement that allows storage of the working conjugate solution at room temperature for 30 hours, up to 10 cycles of 3 hours at room temperature allowed for the device.