PMA
P220034: LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus
FDA PMA · ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG · DiaSorin, Inc.
Key facts
| PMA number | P220034 |
|---|---|
| Trade name | LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus |
| Generic name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Product code | MYL |
| Approval date | Mar 29, 2024 |
| Docket number | 24M-1612 |
| Notice date | Apr 5, 2024 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 10–99 Supplements
- Aug 18, 2026 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- No Withdrawn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: