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

FDA product code LOM · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3172
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-06-04 – 2026-06-04

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.

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