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 | cobas® HPV |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 |
PMA Number | P190028 |
Supplement Number | S007 |
Date Received | 11/01/2022 |
Decision Date | 10/04/2023 |
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 |
Approval Order Statement A new instrument, the cobas 5800 System, in addition to the existing cobas 6800/8800 Systems, for use with cobas HPV. |
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