|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Replacement of key equipment used in performing the coated well test procedure and the acceptance criteria associated with its use. In addition, the coated well sampling plan, randomization methods for sampling, and test error correction methods have been improved to further ensure batch quality and reduction of production waste for the manufacture of the coated microwells.