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 HCV |
Generic Name | assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Applicant |
Roche Molecular Systems, Inc. |
4300 hacienda drive |
pleasanton, CA 94588-2722 |
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PMA Number | P150015 |
Supplement Number | S031 |
Date Received | 05/09/2019 |
Decision Date | 06/06/2019 |
Product Code |
MZP
|
Advisory Committee |
Microbiology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Scale up for manufacturing of a sub-bulk reagent and subsequent changes to filling operations for a critical component. |
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