PMA supplement
BP950004 S005: OraSure HIV-1 Western Blot Kit
FDA PMA supplement · 135 Day Track for 30 Day Notification · OraSure Technologies, Inc
Key facts
| Original PMA | BP950004 |
|---|---|
| Supplement number | S005 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | OraSure HIV-1 Western Blot Kit |
| Generic name | Point of care hiv serology diagnostic and/or supplemental test |
| Applicant | OraSure Technologies, Inc |
| Product code | QSU |
| Received date | Oct 8, 2004 |
| Decision date | Jan 27, 2005 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: