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 TAQMAN HBV TEST |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P050028 |
Supplement Number | S013 |
Date Received | 02/08/2011 |
Decision Date | 02/24/2011 |
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 ELIMINATION OF THE IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE COMPONENT OF THE MASTER MIX USED WITH THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER (PMC) FACILITY IN BRANCHBURG, NEW JERSEY. |
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