|
Device | DIGENE HYBRID CAPTURE HPV DNA TEST |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | QIAGEN GAITHERSBURG, INC 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P890064 |
Supplement Number | S017 |
Date Received | 11/19/2004 |
Decision Date | 12/14/2004 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | 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. |