SEI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Qualitative And Quantitative Hepatitis B Virus Antibody Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3173
- Medical specialty
- Microbiology
- FDA definition
- In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBc IgM (K260049) | Roche Diagnostics | 2026-04-07 |
| Elecsys Anti-HBc II (K260046) | Roche Diagnostics | 2026-04-07 |
| Access anti-HBc IgM (K254059) | Beckman Coulter, Inc. | 2026-03-13 |
| Access anti-HBc Total (K253687) | Beckman Coulter, Inc. | 2026-02-19 |
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Every clearance here is in the API, with alerts when new ones post.