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 | VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | QIAGEN, INC. 1201 Clopper Road Gaithersburg, MD 20878 |
PMA Number | P880009 |
Supplement Number | S002 |
Date Received | 06/16/1989 |
Decision Date | 08/21/1989 |
Withdrawal Date
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01/29/2010 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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