Panels › Microbiology › Product code SEI · Class 2
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Regulation 866.3173
4510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SEI
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 0 |
| Roche Diagnostics | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 2026 | K260049 | Elecsys Anti-HBc IgM Roche Diagnostics | SEI |
| Apr 7, 2026 | K260046 | Elecsys Anti-HBc II Roche Diagnostics | SEI |
| Mar 13, 2026 | K254059 | Access anti-HBc IgM Beckman Coulter, Inc. | SEI |
| Feb 19, 2026 | K253687 | Access anti-HBc Total Beckman Coulter, Inc. | SEI |
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