PMA
BP190437: LIAISON? XL MUREX Control HIV Ab/Ag HT
FDA PMA · Hiv detection test · DiaSorin, Inc.
Key facts
| PMA number | BP190437 |
|---|---|
| Trade name | LIAISON? XL MUREX Control HIV Ab/Ag HT |
| Generic name | Hiv detection test |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Product code | MZF |
| Approval date | Nov 25, 2020 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 1–9 Supplements
- Jun 14, 2022 Latest supplement decision
- No Withdrawn
- No 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: