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Vaccines, Blood & Biologics

OraSure HIV-1 Western Blot Kit

Proper Name: OraSure HIV-1 Western Blot Kit
Epitope, Inc.

  • 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.

Contact FDA

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

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 01/29/2015
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