|Trade Name||DIGENE HYBRID CAPTURE HPV DNA TEST|
|Classification Name||kit, dna detection, human papillomavirus|
|Generic Name||human papillomavirus dna detection kit|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for packaging quality control material in the hybrid capture 2 hpv dna test kits that was previously provided under a separate product code, as well as the addition of an upper limit for the hpv positive control test values.