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 x 480, cobas HPV Test, 240/960 Tests |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P100020 |
Supplement Number | S032 |
Date Received | 05/09/2018 |
Decision Date | 08/08/2018 |
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 changes in the manufacturer, design, and specifications of the heater/shaker unit of the cobas 480 x Instrument, a component of the cobas 4800 System. |
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