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Vaccines, Blood & Biologics
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Genetic Systems rLAV EIA
Proper Name: Human Immunodeficiency Virus Type 1
Tradename: Genetic Systems rLAV EIA
Manufacturer: Bio-Rad Laboratories, License #1109
Date: June 29, 1998
Indication: New HIV-1 enzyme immunoassay (EIA) which contains a combination of HIV-1 viral lysate and HIV-1 recombinant antigen
June 29, 1998 Approval Letter
Summary Basis of Approval (PDF - 4 MB)
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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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