PMA
P190034: Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Roche Diagnostics
Key facts
| PMA number | P190034 |
|---|---|
| Trade name | Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Roche Diagnostics |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | SEI |
| Approval date | Feb 23, 2021 |
| Docket number | 21M-0228 |
| Notice date | Feb 25, 2021 |
| 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- No Withdrawn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
- 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: