LOM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3172
- Medical specialty
- Microbiology
- FDA definition
- In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.
- Adverse events (MAUDE)
- 2021: 147 · 2022: 139 · 2023: 163 · 2024: 197 · 2025: 383 · 2026: 215
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (K260770) | DiaSorin, Inc. | 2026-06-04 |
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Every clearance here is in the API, with alerts when new ones post.