|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||CERVISTA HPV 16/18|
|Classification Name||kit, dna detection, human papillomavirus|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the increase of the volume of the hpv control in cervista hpb 16/18 test and labeling changes to the package insert.