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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 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.
 
DeviceVERSANT HCV RNA 3.0 ASSAY (BDNA)
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Generic Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
725 potter street
berkeley, CA 94710
PMA NumberP020022
Supplement NumberS010
Date Received12/15/2011
Decision Date12/23/2013
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE VERSANT HCVRNA 3.0 ASSAY (BDNA) FROM 12 TO 18 MONTHS.
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