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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 NameVERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantGEN-PROBE
PMA NumberP020011
Supplement NumberS001
Date Received05/01/2009
Decision Date05/22/2009
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 
Change of the activator used in the synthesis of dna oligonucleotides from 1-h tetrazole to 5-ethylthio 1-h tetrazole (ett) and the addition of sigma-aldrich (safc) as a secondary supplier of the new activator (ett).
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