PMA
BP040046: Multispot HIV-1/HIV-2 Rapid Test
FDA PMA · Hiv detection test · Bio-Rad Laboratories, Inc.
Key facts
| PMA number | BP040046 |
|---|---|
| Trade name | Multispot HIV-1/HIV-2 Rapid Test |
| Generic name | Hiv detection test |
| Applicant | Bio-Rad Laboratories, Inc. |
| Owner/operator | Bio-Rad Laboratories, Inc. |
| Product code | MZF |
| Approval date | Nov 12, 2004 |
| Establishment registration | 3003756338 |
| FEI number | 3003756338 |
At a glance
- 1–9 Supplements
- Nov 25, 2014 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- No Withdrawn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: