Atellica IM Hepatitis B e Antigen (HBeAg)
FDA premarket approval P090024/S012 · decided 2025-01-13
Approval details
- PMA number
- P090024
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Hepatitis B e Antigen (HBeAg)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2024-07-22
- Decision date
- 2025-01-13
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the migration of the ADVIA Centaur HBeAg assay (P090024), from the ADVIA Centaur XP to the Atellica CI analyzer, which will be known as the Atellica IM HBeAg assay.
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