PMA supplement
BP190360 S004: cobas? HIV-1/HIV-2 Qualitative
FDA PMA supplement · Real Time Process · Roche Molecular Systems, Inc.
Key facts
| Original PMA | BP190360 |
|---|---|
| Supplement number | S004 |
| Supplement type | Real Time Process |
| Trade name | cobas? HIV-1/HIV-2 Qualitative |
| Generic name | Lab-based hiv nat diagnostic and/or supplemental test |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | QST |
| Received date | Sep 4, 2020 |
| Decision date | Nov 16, 2020 |
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: