PMA supplement
P010053 S013: IMMULITE 2000/2000 XPi Anti-HBc IgM
FDA PMA supplement · Real-Time Process · Siemens Healthcare Diagnostics Products, Ltd.
Key facts
| Original PMA | P010053 |
|---|---|
| Supplement number | S013 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | IMMULITE 2000/2000 XPi Anti-HBc IgM |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Siemens Healthcare Diagnostics Products, Ltd. |
| Product code | LOM |
| Received date | Dec 22, 2020 |
| Decision date | Mar 11, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: