|Trade Name||VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Generic Name||antibody to hepatitis b core antigen (anti-hbc) assay|
|Supplement Type||real-time process|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a new process step to identify and dilute samples with high result signal-to-cutoff ratio (s/c) above the normal negative population and the changes involved in adding this new process. These changes are an update to the magnetic card and to the labeling of the vitros anti-hbc reagent pack to support the identification, dilution and testing of the high negative samples.