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Approval for the vitros immunodiagnostic products anti-hbs reagent pack and calibrators. The device is indicated for: the qualitative in vitro determination of total antibody to hepatitis b surface antigen (anti-hbs) in human serum using the vitros eci immunodiagnostic system. Assay results may be used as an aid in the determinatino of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.
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