PMA
BP120001: OraQuick® In-Home HIV Test
FDA PMA · Hiv self-tests · OraSure Technologies, Inc
Key facts
| PMA number | BP120001 |
|---|---|
| Trade name | OraQuick® In-Home HIV Test |
| Generic name | Hiv self-tests |
| Applicant | OraSure Technologies, Inc |
| Owner/operator | ORASURE TECHNOLOGIES, INC. |
| Product code | QSS |
| Approval date | Jul 3, 2012 |
| Establishment registration | 3022474803 |
| FEI number | 3022474803 |
At a glance
- 10–99 Supplements
- May 25, 2023 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: