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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2004 Biological Device Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date; it is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval. 


Tradename Description and Indication for Device Applicant Number Approval Date
OraQuick Rapid HIV-1/2 Antibody Test Addition to the intended use statement to include detection of antibodies to HIV-2 OraSure Technologies
150 Webster Street
Bethlehem, PA 18015-1389
BP010047/12 3/19/2004
OraQuick Rapid HIV-1/2 Antibody Test 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 OraSure Technologies
220 East First St
Bethlehem, PA 18015-1360
BP010047/10 3/26/2004
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Added labeling claim for the detection of HIV-2 antibodies in oral fluid and a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test OraSure Technologies
220 East First St
Bethlehem, PA 18015-1360
BP010047/16 6/22/2004