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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.
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameassay,enzyme linked immunosorbent,hepatitis c virus
Abbott Laboratories
100 abbott park rd.
ap5n-2 dept 09vb
abbott park, IL 60064-3500
PMA NumberP970027
Date Received07/01/1997
Decision Date02/05/2004
Withdrawal Date 11/08/2013
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
Recalls CDRH Recalls
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018