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Auszyme Monoclonal
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
Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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