PMA
P050051: ABBOTT ARCHITECT AUSAB
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Abbott Laboratories, Inc.
Key facts
| PMA number | P050051 |
|---|---|
| Trade name | ABBOTT ARCHITECT AUSAB |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Abbott Laboratories, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | SEI |
| Approval date | Jun 1, 2006 |
| Docket number | 06M-0321 |
| Notice date | Aug 17, 2006 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Apr 3, 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- No Withdrawn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: