|
Device | DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH 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 | S026 |
Date Received | 02/28/2011 |
Decision Date | 04/20/2011 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE DESIGN CHANGE OF THE HC2 SYSTEM SUITE CONSISTING OF AN HC2 SYSTEM SOFTWARE UPGRADE FROM VERSION 2.0 TO VERSION 3.0. |