PMA
P100032: ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Roche Diagnostics Corp.
Key facts
| PMA number | P100032 |
|---|---|
| Trade name | ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Roche Diagnostics Corp. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | SEI |
| Approval date | Jun 27, 2011 |
| Docket number | 11M-0503 |
| Notice date | Jul 1, 2011 |
| 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- No Withdrawn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: