PMA
BP150318: Aptima HIV-1 Quant Dx assay
FDA PMA · Human immunodeficiency virus (hiv) viral load monitoring test · Hologic, Inc.
Key facts
| PMA number | BP150318 |
|---|---|
| Trade name | Aptima HIV-1 Quant Dx assay |
| Generic name | Human immunodeficiency virus (hiv) viral load monitoring test |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | QUM |
| Approval date | Dec 22, 2016 |
| Establishment registration | 2024800 |
| FEI number | 2024800 |
At a glance
- 10–99 Supplements
- Dec 19, 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- No Withdrawn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: