LOM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Product code

LOM

Device name

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Device class

Class 2

21 CFR

21 CFR 866.3172

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification 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.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-06-04.

1 summaries are archived here for direct download.