PMA
P180045: LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · DiaSorin, Inc.
Key facts
| PMA number | P180045 |
|---|---|
| Trade name | LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Product code | SEI |
| Approval date | Aug 29, 2020 |
| Docket number | 20M-1828 |
| Notice date | Sep 3, 2020 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 10–99 Supplements
- Oct 10, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: