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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 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
725 POTTER STREET
BERKELEY, CA 94710
PMA NumberP020022
Supplement NumberS007
Date Received03/20/2009
Decision Date04/14/2009
Withdrawal Date 02/26/2015
Product Code MZP 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES TO THE 440 SYSTEM SOFTWARE AND DMS SOFTWARE (RELEASE 3).
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