|Trade Name||CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)|
|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 to replace quality control test method controls with new quality control test method controls from the same supplier for incoming materials inspection testing and in-process quality control testing of accessory kit reagents.