Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
LOM · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3172
Classification
FDA Product Code
LOM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3172
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.