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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP000012
Supplement NumberS018
Date Received11/24/2008
Decision Date12/04/2008
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Replacement of tetrazole, an activator used in the automated dna synthesis of rms oligonucleotides used in the cobas ampliprep/cobas amplicor hcv test with the activator, 4,5 dicyanoimidazole (dci).
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