PMA supplement
BP140120 S007: Geenius? HIV 1/2 Supplemental Assay
FDA PMA supplement · 30-Day Notice · Bio-Rad Laboratories, Inc.
Key facts
| Original PMA | BP140120 |
|---|---|
| Supplement number | S007 |
| Supplement type | 30-Day Notice |
| Trade name | Geenius? HIV 1/2 Supplemental Assay |
| Generic name | Point of care hiv serology diagnostic and/or supplemental test |
| Applicant | Bio-Rad Laboratories, Inc. |
| Product code | QSU |
| Received date | Jun 19, 2017 |
| Decision date | Jul 18, 2017 |
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: