|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||BIOTRON PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|
|Classification Name||assay,enzyme linked immunosorbent,parvovirus b19 igm|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding a quality assurance inspection step.