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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.
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
Supplement NumberS001
Date Received08/03/2010
Decision Date02/18/2011
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 11M-0132
Notice Date 03/09/2011
Advisory Committee Microbiology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the oraquick hcv rapid antibody test is a single-use immunoassay for the qualitative detection of antibodies to hepatitis c virus (anti-hcv) in fingerstick whole blood specimens and 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