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 TAQMAN HBV TEST |
Generic Name | hepatitis viral b dna detection |
Applicant |
Roche Molecular Systems, Inc. |
4300 hacienda drive |
pleasanton, CA 94588-2722 |
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PMA Number | P050028 |
Supplement Number | S051 |
Date Received | 04/18/2016 |
Decision Date | 05/13/2016 |
Product Code |
MKT
|
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
Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory. |
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