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Premarket Approval Information - Devices

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Applicant: OraSure Technologies, Bethlehem, PA
Product: OraQuick Rapid HIV-1/2 Antibody Test
PMA number: BP010047/10
Indication for Use: Allow for an added labeling claim for the detection of antibodies to HIV-1 and HIV-2 in plasma specimens and the detection of HIV-1 antibodies in oral fluid specimen
Approval Date: 3/26/2004

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Letter - (Text)

Label - (PDF)

Control Kit - (PDF)

Subject Information - (PDF)

Talkpaper

 

Updated February 9, 2005
 
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