Product code LOM

Device name

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

Medical specialty

Microbiology

Device class

2

Regulation number

866.3172

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset