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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.
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