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Vaccines, Blood & Biologics
Genetic Systems HBsAg EIA 3.0
Proper Name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) (Antibody to HBsAG/Enzyme Immuno Assay (EIA))
Tradename: Genetic Systems HBsAg EIA 3.0
Manufacturer: Bio-Rad Laboratories, License #1109
Package Insert (PDF - 344 KB) - January, 2003
Date: January 23, 2003
Indication: Detection of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma, and also in cadaveric serum specimens
January 23, 2003 Approval Letter (PDF - 55 KB)
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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