PMA
BP150262: cobas HIV-1
FDA PMA · Human immunodeficiency virus (hiv) viral load monitoring test · Roche Molecular Systems, Inc.
Key facts
| PMA number | BP150262 |
|---|---|
| Trade name | cobas HIV-1 |
| Generic name | Human immunodeficiency virus (hiv) viral load monitoring test |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | QUM |
| Approval date | Dec 18, 2015 |
| Establishment registration | 3004141078 |
| FEI number | 1000121742 |
At a glance
- 10–99 Supplements
- Oct 26, 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- No Withdrawn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: