2003 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 |
|---|---|---|---|---|
| Calypte HIV-1 Urine EIA | Changes to the black box warning statement | Calypte Biomedical Corp 1265 Harbor Bay Parkway Alameda, CA 94502 |
BP000009 / 3 | 1/29/2003 |
| OraQuick Rapid HIV-1 Antibody Test | Allow for a labeling claim for the detection of antibodies to HIV-1 in venipuncture whole blood specimens and to reduce the maximum read time from 60 minutes to 40 minutes | OraSure Technologies, Inc 150 Webster St Bethlehem, PA 18015-1389 |
BP010047 / 7 | 9/5/2003 |