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FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3172
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
32
510(K)/PMA CLEARANCES
pma: 31 · 510k: 1
0
RECALL ENTRIES

Recent clearances

K260770DiaSorin, Inc. · 510k2026-06-04
P210019Siemens Healthcare Diagnostics, Inc. · pma2025-10-17
P090024Siemens Healthcare Diagnostics · pma2025-10-17
P110041Siemens Corp. · pma2025-10-17
P030040Siemens Healthcare Diagnostics · pma2025-10-17
P100039Siemens Healthcare Diagnostics, Inc. · pma2025-10-17
P200017Siemens Healthcare Diagnostics, Inc. · pma2025-10-17
P230015Beckman Coulter, Inc. · pma2025-10-17

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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