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Device | digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | QIAGEN GAITHERSBURG, INC 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P890064 |
Supplement Number | S033 |
Date Received | 02/19/2016 |
Decision Date | 04/15/2016 |
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 a new version of the HC2 Software Suite (version 4.4) and a new hardware model of the PC used with this software. |