PMA
P130015: ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Roche Diagnostics Operations, Inc.
Key facts
| PMA number | P130015 |
|---|---|
| Trade name | ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Roche Diagnostics Operations, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | LOM |
| Approval date | Mar 14, 2014 |
| Docket number | 14M-0326 |
| Notice date | Mar 31, 2014 |
| Establishment registration | 1823260 |
| FEI number | 1823260 |
At a glance
- 10–99 Supplements
- May 22, 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- No Withdrawn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: