|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||APTIMA HPV 16 18/45 GENOTYPE ASSAY|
|Classification Name||kit, rna detection, human papillomavirus|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Scale-up of a bulk solution, increase in the bulk hold time, and qualification of a new manufacturing filling system.