PMA supplement
BP120037 S018: Alere DetermineTM HIV-1/2 Ag/Ab Combo
FDA PMA supplement · 30-Day Notice · Abbott Diagnostics Scarborough
Key facts
| Original PMA | BP120037 |
|---|---|
| Supplement number | S018 |
| Supplement type | 30-Day Notice |
| 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 |
| Product code | QSU |
| Received date | Jan 30, 2019 |
| Decision date | Feb 26, 2019 |
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: