- Device
- VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S017
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2023-01-24
- Decision code
- APPR
- Date received
- 2022-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the package insert to include information on biotin interference.