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. |
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Device | DIGENE HC2 SYSTEM SOFTWARE |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | QIAGEN GAITHERSBURG, INC 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P890064 |
Supplement Number | S031 |
Date Received | 09/23/2014 |
Decision Date | 10/09/2014 |
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 THE UPGRADE OF THE HC2 SOFTWARE SUITE TO VERSION 4.3. |
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