PMA
P190011: LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · DiaSorin, Inc.
Key facts
| PMA number | P190011 |
|---|---|
| Trade name | LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Product code | MZO |
| Approval date | Oct 18, 2019 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 1–9 Supplements
- Aug 10, 2021 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- No Withdrawn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: