LOM — Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Class II
FDA product code LOM covers "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)", a Class II medical device regulated under 21 CFR 866.3172. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260770 | diasorin | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | June 4, 2026 |