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 AMPLIPREP/COBAS AMPLICOR HVC TEST |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | Roche Molecular Systems, Inc. 4300 HACIENDA DR. PLEASANTON, CA 94588-0900 |
PMA Number | P000012 |
Supplement Number | S025 |
Date Received | 08/27/2010 |
Decision Date | 09/23/2010 |
Withdrawal Date
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08/26/2016 |
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 CHANGES TO REDUCE THE BATCH SIZE FOR MANUFACTURE OF SUBSTRATE A, SUBATRATE B, STOP REAGENT AND WASH CONCENTRATE BULK SOLUTION. |
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