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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameABBOTT AXSYM ANTIBODY TO HCV
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameantibody to hepatitis c virus
ApplicantABBOTT LABORATORIES
PMA NumberP970027
Date Received07/01/1997
Decision Date02/05/2004
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 04M-0207
Notice Date 05/05/2004
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the abbott axsym antibody to hcv. The device is indicated for the qualitative detection of anti-hcv recombinant proteins in human serum or plasma (potassium edta, sodium edta, sodium heparin, lithium heparin, sodium citrate, and potassium oxalate).
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
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