PMA
P200013: Alinity m HBV
FDA PMA · Hepatitis Viral B DNA Detection · Abbott Molecular, Inc.
Key facts
| PMA number | P200013 |
|---|---|
| Trade name | Alinity m HBV |
| Generic name | Hepatitis Viral B DNA Detection |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MKT |
| Approval date | Aug 29, 2020 |
| Docket number | 20M-1830 |
| Notice date | Sep 30, 2020 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Oct 17, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: