PMA
BP190360: cobas? HIV-1/HIV-2 Qualitative
FDA PMA · Lab-based hiv nat diagnostic and/or supplemental test · Roche Molecular Systems, Inc.
Key facts
| PMA number | BP190360 |
|---|---|
| Trade name | cobas? HIV-1/HIV-2 Qualitative |
| Generic name | Lab-based hiv nat diagnostic and/or supplemental test |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | QST |
| Approval date | Aug 12, 2020 |
| Establishment registration | 3004141078 |
| FEI number | 2243470 |
At a glance
- 1–9 Supplements
- Oct 31, 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- No Withdrawn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: