PMA supplement
P210019 S002: ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
FDA PMA supplement · Panel Track · Siemens Healthcare Diagnostics, Inc.
Key facts
| Original PMA | P210019 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | LOM |
| Received date | Oct 31, 2022 |
| Decision date | Apr 28, 2023 |
| Docket number | 23M-1698 |
| Notice date | May 1, 2023 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: