PMA
P210019: ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Siemens Healthcare Diagnostics, Inc.
Key facts
| PMA number | P210019 |
|---|---|
| Trade name | ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | SEI |
| Approval date | Jul 27, 2022 |
| Docket number | 22M-1740 |
| Notice date | Jul 29, 2022 |
| Establishment registration | 1219913 |
| FEI number | 1219913 |
At a glance
- 1–9 Supplements
- Oct 17, 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- No Withdrawn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: