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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 3.0 ASSAY (BDNA)
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP020022
Supplement NumberS010
Date Received04/09/2012
Decision Date12/23/2013
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extension of the shelf-life of the versant hcv rna 3. 0 assay (bdna) from 12 to 18 months.
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