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

FDA Device Classification

Classification Details

Product Code
LOM
Device Class
Class II
Regulation Number
866.3172
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.