PMA
P010052: IMMULITE 2000 XPI ANTI-HBS
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Siemens Healthcare Diagnostics Products, Ltd.
Key facts
| PMA number | P010052 |
|---|---|
| Trade name | IMMULITE 2000 XPI ANTI-HBS |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Siemens Healthcare Diagnostics Products, Ltd. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | SEI |
| Approval date | Jul 22, 2002 |
| Docket number | 03M-0287 |
| Notice date | Jun 24, 2003 |
| Establishment registration | 3002806944 |
| FEI number | 3002806944 |
At a glance
- 10–99 Supplements
- Sep 18, 2025 Latest supplement decision
- No Withdrawn
- Yes 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: