Vaccines, Blood & Biologics
Genetic Systems HIV-1/HIV-2 Plus O EIA
Proper Name: Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic)
Tradename: Genetic Systems HIV-1/HIV-2 Plus O EIA
Manufacturer: Bio-Rad Laboratories, License #1109
Package Insert (PDF - 408 KB) - Approved: August 5, 2003
Date: August 5, 2003
Indication: Detection of antibodies to the Human Immunodeficiency Virus Types 1 and 2 in human serum and plasma
August 5, 2003 Approval Letter (PDF - 244 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

