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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 NameABBOTT REALTIME HCV
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP100017
Supplement NumberS004
Date Received02/05/2013
Decision Date03/01/2013
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the configuration of the current label printer, label printing software, and label inspection system at the des plaines, illinois manufacturing site.
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