PMA
P160019: Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Roche Diagnostics, Inc.
Key facts
| PMA number | P160019 |
|---|---|
| Trade name | Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Roche Diagnostics, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | LOM |
| Approval date | Dec 23, 2016 |
| Docket number | 16M-4530 |
| Notice date | Jan 18, 2017 |
| Establishment registration | 9610529 |
| FEI number | 3002806560 |
At a glance
- 10–99 Supplements
- May 22, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: