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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 AXSYM ANTI-HCV
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameantibody to hepatitis c virus
ApplicantABBOTT LABORATORIES
PMA NumberP970027
Supplement NumberS008
Date Received04/22/2010
Decision Date05/13/2010
Product Code
MZO[ Registered Establishments with MZO ]
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 efficacy testing performed on new incoming lots of conjugate concentrate for the device.
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