# Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
> **Product code: LOM** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3172
## Classification
- **FDA Product Code:** LOM
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3172
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 25
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=LOM)
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