|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.|
|Classification Name||kit, dna detection, human papillomavirus|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for several changes to the cervista hpv 16/18 software and labeling. Changes include the company name change from third wave to hologic, numerous user interface changes, and separating the invader call reporter and cervista hpv 16/18 software on to separate cds with new part numbers.