PMA supplement
BP140120 S011: Bio-Rad Geenius HIV 1/2 Supplemental Assay
FDA PMA supplement · Normal 180 Day Track · Bio-Rad Laboratories, Inc.
Key facts
| Original PMA | BP140120 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track |
| Trade name | Bio-Rad 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 | Jul 9, 2019 |
| Decision date | Sep 10, 2019 |
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: