Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core IgM) is a panel of serological diagnostic tests used to detect hepatitis B core antigen, hepatitis B e antigen, antibody to hepatitis B e antigen, and IgM antibody to hepatitis B core antigen, collectively used to determine the phase of hepatitis B infection, infectivity, and immune response. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LOM; no regulation number has been assigned, and the review panel is Microbiology. No special flags apply to this device.
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Basic Information
- Product Code
- LOM
- Device Class
- FDA class 2
- Regulation Number
- 866.3172
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | Jun 04, 2026 | Substantially Equivalent | DiaSorin, Inc. |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.