Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | DIGENE HYBRID CAPTURE 2 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 | S012 |
Date Received | 05/20/2003 |
Decision Date | 06/20/2003 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION OF LOT RELEASE TESTING FOR DETECTION REAGENT 1 (DR1) COMPONENT. |
|
|