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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 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP020022
Supplement NumberS007
Date Received03/20/2009
Decision Date04/14/2009
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software changes to the 440 system software and dms software (release 3).
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