Vaccines, Blood & Biologics
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ABBOTT PRISM HIV O Plus
Proper Name: Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide
Tradename: ABBOTT PRISM HIV O Plus
Manufacturer: Abbott Laboratories
Indication:
- For the detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma specimens
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Supporting Documents
September 18, 2009 Approval Letter - ABBOTT PRISM HIV O Plus
for the detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma specimens
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Contact FDA
(800) 835-4709
(301) 827-1800
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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