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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.
 
DeviceBAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)
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 NumberS005
Date Received12/20/2006
Decision Date08/01/2007
Withdrawal Date 02/26/2015
Product Code MZP 
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR TRANSFER OF THE MANUFACTURE OF THE WASH REAGENTS (WASH A AND WASH B) TO A CONTRACT MANUFACTURER. THE NUMBER OF BOTTLES PER LOT WILL BE INCREASED FOR BOTH WASH A AND WASH B.
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