# Qualitative And Quantitative Hepatitis B Virus Antibody Assays
> **Product code: SEI** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3173
## Classification
- **FDA Product Code:** SEI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3173
- **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 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.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 18
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SEI)
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