PMA
BP140111: BioPlex? 2200 HIV Ag-Ab
FDA PMA · Hiv detection test · Bio-Rad Laboratories
Key facts
| PMA number | BP140111 |
|---|---|
| Trade name | BioPlex? 2200 HIV Ag-Ab |
| Generic name | Hiv detection test |
| Applicant | Bio-Rad Laboratories |
| Owner/operator | BIO-RAD LABORATORIES, INC. |
| Product code | MZF |
| Approval date | Jul 23, 2015 |
| Establishment registration | 3007886270 |
| FEI number | 3008272466 |
At a glance
- 1–9 Supplements
- Feb 6, 2019 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: