ASSAY
Product: OraSure HIV-1 Western Blot Kit Applicant:
Epitope, Inc., Beaverton, OR PMA number: BP950004
Indication for use: 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.
Approval Date: 6/3/96
http://www.fda.gov/CBER/pma/P950004.htm
summary:
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