Atellica IM Anti-HBe2 (aHBe2)
FDA premarket approval P200017/S005 · decided 2025-10-17
Approval details
- PMA number
- P200017
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Anti-HBe2 (aHBe2)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2025-08-04
- Decision date
- 2025-10-17
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the Atellica CI Analyzer with Atellica Sample Handler configuration for Atellica IM HBcT2, aHBs2, HBeAg, aHBcM, aHBe2, HBsII & HBsII Conf assays.
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