|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|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a software revision change from cervista hpv 16/18 v5. 4 to cervista hpv 16/18 v6. 0.