PMA
BP100064: GS HIV Combo Ag/Ab EIA
FDA PMA · Hiv detection test · Bio-Rad Laboratories, Inc.
Key facts
| PMA number | BP100064 |
|---|---|
| Trade name | GS HIV Combo Ag/Ab EIA |
| Generic name | Hiv detection test |
| Applicant | Bio-Rad Laboratories, Inc. |
| Owner/operator | Bio-Rad Laboratories, Inc. |
| Product code | MZF |
| Approval date | Jul 22, 2011 |
| Establishment registration | 3003756338 |
| FEI number | 3003756338 |
At a glance
- 1–9 Supplements
- Oct 17, 2018 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: