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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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OraSure HIV-1 Western Blot Kit

Proper Name: OraSure HIV-1 Western Blot Kit
Tradename:
None
Manufacturer:
Epitope, Inc.
Indication:

  • In-vitro qualitative assay for the detection of antibodies to HIV-1 in human oral fluid specimens obtained with the Orasure HIV-1 Oral Specimen Collection Device; and as an additional, more specific test for HIV-1 antibodies in OraSure specimens collected from individuals found to be repeatedly reactive by the Oral Fluid Vironostika HIV-1 Microelisa System screening test manufactured by Organon Teknika Corp.
 

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(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

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Food and Drug Administration

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Building 71 Room 3103

Silver Spring, MD 20993-0002