Product Approval Information
Proper Name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA)/Monoclonal
Tradename: Auszyme Monoclonal
Manufacturer: Abbott Laboratories, License #0043
Label (PDF - 138 KB) - December, 2001
Label (Confirmatory Assay) (PDF - 83 KB) - December, 2001
Date: December 19, 2001
Labeling Change: To extend the indications for use to include cadaveric serum specimen testing
December 19, 2001 Approval Letter