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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2003 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
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