PMA
P080026: ABBOTT REALTIME HBV ASSAY
FDA PMA · Hepatitis Viral B DNA Detection · Abbott Molecular, Inc.
Key facts
| PMA number | P080026 |
|---|---|
| Trade name | ABBOTT REALTIME HBV ASSAY |
| Generic name | Hepatitis Viral B DNA Detection |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MKT |
| Approval date | Aug 13, 2010 |
| Docket number | 10M-0519 |
| Notice date | Oct 1, 2010 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Apr 18, 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- No Withdrawn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: