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 FOR USE WITH THE HIGH PURE SYSTEM |
Applicant |
Roche Molecular Systems, Inc. |
4300 hacienda drive |
pleasanton, CA 94588-2722 |
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PMA Number | P050028 |
Supplement Number | S007 |
Date Received | 01/08/2010 |
Decision Date | 02/04/2010 |
Advisory Committee |
Microbiology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
ELIMINATION OF IN-PROCESS CHEMICAL TESTING OF A BUFFER CONCENTRATE USED TO PREPARE THE MASTER MIX COMPONENT OF THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. |
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