PMA
BP120037: Alere DetermineTM HIV-1/2 Ag/Ab Combo
FDA PMA · Point of care hiv serology diagnostic and/or supplemental test · Abbott Diagnostics Scarborough
Key facts
| PMA number | BP120037 |
|---|---|
| Trade name | Alere DetermineTM HIV-1/2 Ag/Ab Combo |
| Generic name | Point of care hiv serology diagnostic and/or supplemental test |
| Applicant | Abbott Diagnostics Scarborough |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | QSU |
| Approval date | Aug 8, 2013 |
| Establishment registration | 1221359 |
| FEI number | 1221359 |
At a glance
- 10–99 Supplements
- Jan 28, 2022 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: