LOMClass II

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

21 CFR 866.3172 / Microbiology

LOM is the FDA product code for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen), a class II device type, regulated under 21 CFR 866.3172. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2026-06-04, and 33 recalls.

Classification record

Product code: LOM
Device name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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.
Regulation: 21 CFR 866.3172
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 33

Clearances, product code LOM

By decision year

1 clearance under product code LOM with a decision year between 2026 and 2026, 2026 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code LOM by decision year
Year	Clearances
2026	1

Applicants with the most clearances

Product code LOM

Applicants holding the most 510(k) clearances under product code LOM
Applicant	Clearances
Diasorin Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order