PMA supplement
BP040046 S015: Multispot HIV-1/HIV-2 Rapid Test
FDA PMA supplement · Normal 180 Day Track · Bio-Rad Laboratories, Inc.
Key facts
| Original PMA | BP040046 |
|---|---|
| Supplement number | S015 |
| Supplement type | Normal 180 Day Track |
| Trade name | Multispot HIV-1/HIV-2 Rapid Test |
| Generic name | Hiv detection test |
| Applicant | Bio-Rad Laboratories, Inc. |
| Product code | MZF |
| Received date | Sep 27, 2012 |
| Decision date | Mar 25, 2013 |
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: