|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 HR TEST|
|Classification Name||kit, dna detection, human papillomavirus|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an alternative vendor for cervista® hpv oligos mix 1, mix 2, mix 3 used in the cervista® hpv hr test.