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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 NameBAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantBAYER HEALTHCARE, LLC
PMA NumberP020022
Supplement NumberS005
Date Received12/20/2006
Decision Date08/01/2007
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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