Premarket Approval Information - Devices
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
Letter -
(PDF),
(Text)
Summary - (PDF)
Label - (PDF)
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