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 HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM |
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 Drive Pleasanton, CA 94588-2722 |
PMA Number | P060030 |
Supplement Number | S015 |
Date Received | 02/08/2011 |
Decision Date | 02/24/2011 |
Reclassified Date
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12/22/2021 |
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 ELIMINATION OF THE IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE COMPONENT OF THE MASTER MIX USED WITH THE COBAS TAQMAN HCV TEST, V2.0 WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER (PMC) FACILITY IN BRANCHBURG, NEW JERSEY. |
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