SEI

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

Product code

SEI

Device name

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

Device class

Class 2

21 CFR

21 CFR 866.3173

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-04-07.

4 summaries are archived here for direct download.