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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
220 east first street
bethlehem, PA 18015
PMA NumberP080027
Date Received10/24/2008
Decision Date06/25/2010
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 10M-0402
Notice Date 07/30/2010
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the oraquick rapid hcv antibody test. The device is indicated for the qualitative detection of antibodies to hepatitis c virus (anti-hcv) in venipuncture whole blood specimens (edta, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. The oraquick hcv rapid antibody test results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hcv (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis c infection.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S003 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S021 
S022 S023 S024