2004 Biological Device Application Supplement Approvals for New Indications
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 |