Atellica IM Hepatitis B core IgM (aHBcM)
FDA premarket approval P030040/S024 · decided 2025-10-17
Approval details
- PMA number
- P030040
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Hepatitis B core IgM (aHBcM)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- 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
- East Walpole, MA
- 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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