|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the statistical method employed during incoming material inspection of the hpv controls of the cervista® hpv 16/18 and reagents in the genfind® dna extraction kit.