PMA supplement
BP060002 S037: Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott RealTime HIV-1 Calibrators; Abbott RealTime HIV-1 Controls
FDA PMA supplement · 30-Day Notice · Abbott Molecular
Key facts
| Original PMA | BP060002 |
|---|---|
| Supplement number | S037 |
| Supplement type | 30-Day Notice |
| Trade name | Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott RealTime HIV-1 Calibrators; Abbott RealTime HIV-1 Controls |
| Generic name | Human immunodeficiency virus (hiv) viral load monitoring test |
| Applicant | Abbott Molecular |
| Product code | QUM |
| Received date | Nov 10, 2014 |
| Decision date | Dec 9, 2014 |
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: