PMA
P050048: MONOLISA ANTI-HBS EIA
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Bio-Rad Laboratories
Key facts
| PMA number | P050048 |
|---|---|
| Trade name | MONOLISA ANTI-HBS EIA |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Bio-Rad Laboratories |
| Owner/operator | BIO-RAD LABORATORIES, INC. |
| Product code | SEI |
| Approval date | Aug 25, 2006 |
| Docket number | 07M-0151 |
| Notice date | Apr 19, 2007 |
| Establishment registration | 3007886270 |
| FEI number | 3008272466 |
At a glance
- 10–99 Supplements
- Apr 18, 2025 Latest supplement decision
- No Withdrawn
- Yes 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: